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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

LNK International, Inc.: Equate Night-time Sleep Aide Recalled for Microbial Contamination

Agency Publication Date: July 28, 2019
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Summary

Approximately 300,456 units of Equate Night-time Sleep Aide (diphenhydramine HCl) are being recalled because the berry-flavored liquid may be contaminated with microbes. This over-the-counter sleep medicine was sold in 12-ounce bottles at Walmart stores nationwide. Consumers who have purchased this product should not use it, as it may contain bacteria that could cause illness, particularly in individuals with weakened immune systems.

Risk

The product was found to have microbial contamination, which means it contains bacteria or other microorganisms that should not be present in a non-sterile medication. Ingesting contaminated medicine can lead to infections or digestive illness, especially for vulnerable populations.

What You Should Do

  1. Locate your bottle of Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Berry Flavor, 12 Fl. Oz. (354 mL) and check the label for UPC 6 8113117595 1 and NDC 49035-330-02.
  2. Check the back or side of the bottle for Lot numbers P300456, P300475, P300482, or P300489 with an expiration date of 09/30/2020.
  3. Stop using the medication immediately if the lot numbers match the affected list.
  4. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or to find an alternative treatment.
  5. Return any unused product to your local Walmart pharmacy for a refund and contact LNK International, Inc. at 55 Arkay Dr, Hauppauge, New York for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor (12 Fl. Oz.)
Model:
NDC 49035-330-02
UPC Codes:
681131175951
Lot Numbers:
P300456 (Exp 09/30/2020)
P300475 (Exp 09/30/2020)
P300482 (Exp 09/30/2020)
P300489 (Exp 09/30/2020)
Date Ranges: Expiration date 09/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83315
Status: Resolved
Manufacturer: LNK International, Inc.
Sold By: Walmart
Manufactured In: United States
Units Affected: P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
Distributed To: Nationwide
Agency Last Updated: August 6, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.