Recall and Alerts
At ESSENTIALITIES, we care about the safety of you and your families.
As a supplier for many of the products used on your person or family, it is important for ESS to keep you informed of any product that has been provided in our Prepackaged Kits.
Below you will find an up-to-date list of our recalls. We also encourage you to stay on top of additional product recall and safety information at the U.S. FDA Site at www.recalls.gov.
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We ask you check our Recall List below, for the latest product recalls.
You may also find this information at the Food and Drug Administration site as well.
Please discontinue Recalled products immediately and properly dispose.
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Thank you,
ESSENTIALITIES TEAM
Recall Links
PHARMEDICA
At ESSENTIALITIES® we pride our company on using quality products with quality ingredients in our Prepackaged Kits.
ESSENTIALITIES® will continue to be mindful of your family and household's health and well-being and continue to not only keep you up to date on the latest Recall information, but also ensure each product provided is carefully inspected, before considered in your Prepackaged Kits.
We hope for a quick and positive resolution and look forward to having these items continue in our Households, and ESSENTIALITIES® Prepackaged Kits.
PHARMEDICA
​Information provided from Food and Drug Administration
Summary
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Company Announcement Date: March 03, 2023
FDA Publish Date: March 03, 2023
Product Type: Drugs
Reason for Announcement: Non-sterility
Company Name: Pharmedica USA LLC
Brand Name: Purely Soothing
Product Description: 15% MSM Drops
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Company Announcement
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Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.
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Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.
To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.
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Product was distributed Worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).
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The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles.
The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels below.
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Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.
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Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or e-mail address at osm@pharmedicausa.com Monday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Complete and submit the report Online.
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Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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APO-TEX Corp
​Information provided from Food and Drug Administration
Summary
Date: March 01, 2023
FDA Publish Date: March 02, 2023
Product Type: Drugs
Reason for Announcement: Potential lack of sterility.
Company Name: Apotex Corp.
Brand Name: Apotex
Product Description: Brimonidine Tartrate Ophthalmic Solution, 0.15%
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Company Announcement
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FOR IMMEDIATE RELEASE – March 01, 2023 – Weston, Florida, Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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The six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by NDC numbers stated on the carton and label of the product. The lot number and expiry date are located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode.
These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.
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Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight) and is arranging for return of all recalled product.
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Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy. They should immediately contact their health care provider for medical advice and return the identified lots to Inmar Rx Solutions by contacting at the phone number provided in this press release.
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Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex Corp. can call Inmar Rx Solutions at 1-855-275-1273 (9:00am – 5:00pm, EST Monday thru Friday), to arrange for their return.
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Consumers with the impacted units of Brimonidine Tartrate Ophthalmic Solution, 0.15%, can contact Inmar Rx Solutions at 1-855-275-1273, to receive a recall/return packet including the Recall Stock Response Form (or you may obtain this form from clsnetlink.comExternal Link Disclaimer).
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Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Complete and submit the report Online: www.fda.gov/medwatch/report.htm
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Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
UNILEVER
At ESSENTIALITIES® we love Unilever as our trusted Brand for personal care, in our Prepackaged Kits.
Unilever's long standing and trusted reputation is why we take pride and confidence of this Brand in our
homes, business, and ESSENTIALITIES® Prepackaged Kits.
For many of you who have received product(s) from Unilever, via our Kits or purchased through another vendor/supplier, please visit Unilever website for more information.
ESSENTIALITIES® will continue to supply your Home, Office, and Travel Kits with quality cleaning products and supplies.
We hope for a quick and positive resolution and look forward to having these items continue in our Households, and ESSENTIALITIES® Prepackaged Kits.
UNILEVER
​Information provided from Food and Drug Administration
Company Announcement
FOR IMMEDIATE RELEASE - October 18, 2022 - Englewood Cliffs, New Jersey –
Unilever United States today issued a voluntary product recall to the consumer level of select lot codes of dry shampoo aerosol products produced prior to October 2021 from Dove, Nexxus, Suave, TIGI (Rockaholic and Bed Head), and TRESemmé due to potentially elevated levels of benzene.
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Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.
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Based on an independent health hazard evaluation, daily exposure to benzene in the recalled products at the levels detected in testing would not be expected to cause adverse health consequences. Unilever U.S. is recalling these products out of an abundance of caution. Unilever has received no reports of adverse events to date relating to this recall.
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The recalled products were distributed nationwide in the United States. Retailers have been notified to remove recalled products from shelves.
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A complete list of the affected products produced prior to October 2021 and consumer UPC codes is provided below and can be found hereExternal Link Disclaimer. No other products from Unilever or its brands are impacted by this recall.
An internal investigation identified the propellant as the source, and Unilever has worked with its propellant suppliers to address this issue.
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Consumers should stop using the affected aerosol dry shampoo products and visit UnileverRecall.com for instructions on how to receive reimbursement for eligible products. If consumers have further questions, they may also contact Unilever U.S. by calling (877) 270-7412, Monday through Friday, 8:30 a.m. to 9 p.m. EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Complete and submit the report Online: www.fda.gov/medwatch/report.htm
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Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
THE LAUNDRESS
At ESSENTIALITIES® we love The Laundress. The Laundress products are the Cleaning & Laundry Staple in most of our Household cleaning Home Kits. Unfortunately, these products are on the list of Recalls.
For many of you who have received product(s) from Laundress, via our Kits or purchased through another vendor/supplier, please visit The Laundress website for more information on how to properly discard products, or refund information.
ESSENTIALITIES® will continue to supply your Home, Office, and Travel Kits with quality cleaning products and supplies.
We hope for a quick and positive resolution of The Laundress product recall, as we look forward to having them back in our Households, and ESSENTIALITIES® Prepackaged Kits.
THE LAUNDRESS RECALL
Information below is provided by The Laundress Team
December 1, 2022
Dear Laundress Community,
We are following up on our previous safety notice. Today, The Laundress, in cooperation with the U.S. Consumer Product Safety Commission (CPSC) and Health Canada, issued a voluntary recall of laundry detergent and household cleaning products due to a risk of exposure to bacteria.
The recalled products can contain bacteria, including Burkholderia cepacia complex, Klebsiella aerogenes and multiple different species of Pseudomonas, many of which are environmental organisms found widely in soil and water, and some may also be found in humans. People with weakened immune systems, external medical devices, and underlying lung conditions who are exposed to the bacteria face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, or through the eyes or a break in the skin. People with healthy immune systems are usually not affected by the bacteria.
If you have an impacted product, you should immediately stop using it. To find a complete list of impacted products and request a refund, go to www.TheLaundressRecall.com. If you have already submitted a request for reimbursement following our Safety Notice, there is no need to submit an additional request. However, please do check all your products to see if they are included in the final recall list. For further questions, email customerservice@thelaundress.com or call 800-681-1915 from 9 a.m. to 5 p.m. ET, Monday through Friday.
We deeply apologize to you for this situation. We are undertaking decisive steps with our suppliers to ensure production processes meet our safety and quality standards.
Sincerely,
The Laundress Team
© 2022 The Laundress, All rights reserved.
The Laundress, LLC
247 W. 30th Street, 7F
New York, NY 10001
Johnson & Johnson
At ESSENTIALITIES® we love Johnson & Johnson as our trusted Brand for personal care, in our Prepackaged Kits.
Johnson and Johnson long standing and trusted reputation is why we take pride and confidence of this Brand in our
homes, business, and ESSENTIALITIES® Prepackaged Kits.
For many of you who have received product(s) from Johnson & Johnson via our Kits or purchased through another vendor/supplier, please visit Johnson and Johnson website for more information.
ESSENTIALITIES® will continue to supply your Home, Office, and Travel Kits with quality personal hygiene products.
We hope for a quick and positive resolution and look forward to having these items continue in our Households, and ESSENTIALITIES® Prepackaged Kits.
JOHNSON'S RECALL
Information below is provided by The Food and Drug Administration
October 18, 2019
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The U.S. Food and Drug Administration (FDA) is alerting consumers about Johnson’s Baby Powder Lot #22318RB.
A sample from this lot was found to contain chrysotile fibers, a type of asbestos. On October 18, 2019, Johnson & Johnson voluntarily recalled this product, and consumers who have this lot of baby powder should stop using it.
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The results from the Johnson & Johnson sample are part of our ongoing survey of cosmetic products for asbestos. This survey started in 2018 and involves the testing of about 50 cosmetic products. As part of the same survey of cosmetic products, a Johnson’s Baby Powder sample from a different lot tested negative for asbestos. That sample came from Lot #00918RA.
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The FDA expects to issue the full results of its current set of cosmetics testing by the end of the year. These results will include results from cosmetic products that have tested negative, as well as positive. The FDA has been releasing positive results on an ongoing basis to alert consumers to stop using those products.
The FDA has also been informing individual manufacturers about their tested products that were found to be negative for asbestos as data are finalized.
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The FDA updated a safety alert first issued in March about certain cosmetics that contain asbestos. Previously, the FDA warned consumers not to use certain products from Claire’s and Beauty Plus Global because they tested positive for asbestos. Both companies have recalled those products.
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The FDA will continue to update its safety alert with new information as it becomes available. Consumers may subscribe to receive updates at the bottom of the Cosmetics Recalls and Alerts page.
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Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor
Microbial Contamination
Summary
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Company Announcement Date:
July 15, 2022
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FDA Publish Date:
July 15, 2022
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Product Type:
Drugs
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Reason for Announcement:
Microbial contamination with Gluconacetobacter liquefaciens
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Company Name:
Vi-Jon, LLC
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Brand Name:
Multiple brand names
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Product Description: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
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Company Announcement
July 14, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Gluconacetobacter liquefaciens.
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Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall. Vi-Jon, LLC is in the process of investigating this report.
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The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.
The affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna.
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The product was distributed Nationwide to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.
Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction of all recalled product. Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.
Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail (Recalls@Vijon.com) Monday-Friday, from 7:30 am to 4:30 pm, Central Time.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer
Potential Presence of Undeclared Methanol
SAN ANTONIO - July 24, 2020 - PRLog -- San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).
Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
RECALLED PRODUCTS
These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. This recall now includes all product manufactured by 4e within expiration, regardless of the size, UPC, or lot number. The recalled products are as follows:
The affected Hand Sanitizers are packaged in clear plastic bottles with variation of tops, including blue, white, or clear pumps or caps. The product labels are displayed in the chart above and also included in this press release under images.
The product was distributed nationwide in the United States through retailers and distributors.
4e Brands North America is notifying its distributors and retailers by recall letter and consumers via this press release. 4e Brands North America is arranging for the return and refund of all recalled products.
Consumers/distributors/retailers that have the product subject to this recall should stop using/distributing/ selling the hand sanitizer and return it to the place of purchase.
Consumers with questions regarding this recall can contact 4e Brands North America LLC at:
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Toll Free: 888-843-0254 Mon-Fri 8am – 8 PM Eastern
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FAX: 888-214-7430
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Event: 8797
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Website: https://www.blumensanitizerrecall.expertinquiry.com/
Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to taking or using this product.
Adverse reactions from use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Complete and submit the report Online: www.fda.gov/medwatch/report.htm
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Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
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1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
CONTACT
4e Brands North America
Mon-Fri 8am – 8 PM Eastern
Toll Free: 888-843-0254
FAX: 888-214-7430
https://www.blumensanitizerrecall.expertinquiry.com/
Event: 8797
Contact
4e Brands North America
Mon-Fri 8am – 8 PM Eastern
Toll Free: 888-843-0254
***@stericycle.com
Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers
Potential Presence of Undeclared Methanol
Summary
Company Announcement Date: July 31, 2020
FDA Publish Date: August 18, 2020
Product Type: Drugs
Reason for Announcement: Undeclared Methanol
Company Name: ALBEK de Mexico S.A. de C.V.
Brand Name: Nuuxsan, Modesa, more
Product Description: Hand Sanitizer
These products were distributed nationwide in the United States beginning on November, 15 2019.
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Albek is partnering with its distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled products. Consumers, distributors, and retailers that have product which is being recalled should stop use or distribution and return to place of purchase.
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Consumers with questions regarding this recall can contact Albek de Mexico S.A. de C.V. during the business hours business hours: 9:00am – 5:00pm (CT)
Email: contact@albek.com.mx
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products.
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Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Complete and submit the report Online
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Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
CDER’s press statement: FDA updates on hand sanitizers consumers should not use
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Company Contact Information
Consumers:
Albek de Mexico S.A. de C.V.
(713)961-0262
Media:
Manuel Beltrán M.
52 1 427 101 8200 e
Company Announcement
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SAN JUAN del RIO QUERETARO, Mexico -- ALBEK de Mexico S.A. de C.V. is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. The products were manufactured between November 7, 2019 and June 28, 2020.
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This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product was presented for import into the United States.
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Risk Statement: Substantial methanol exposure could result in serious health effects (including nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, nervous system damage) or death. Persons using methanol-based products on their hands may be at risk.
Young children who accidently ingest them and adolescents and adults who drink such products are most at risk for methanol poisoning. To date, there have been no reports of serious adverse events related to the products in the scope of this recall.
Recalled Products: The products are labeled for use as a hand sanitizer (or “antiseptic”) and are packaged for several nationwide distributors in a variety of formats as indicated in the table as follows: