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

LNK International, Inc.: Acetaminophen Extra Strength Pain Reliever Recalled for Mislabeling

Agency Publication Date: July 16, 2021
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Summary

LNK International, Inc. is recalling 8,472 bottles of Acetaminophen Extra Strength (500 mg) Pain Reliever / Fever Reducer because the label incorrectly describes the tablets as 'enteric coated.' While the product contains the correct medication, the tablets are actually standard coated tablets and do not have the specific enteric coating that allows them to pass through the stomach before dissolving. These products were distributed by Amerisource Bergen in 50-count bottles and were sold in Pennsylvania.

Risk

The product label claims the tablets are 'enteric coated,' which is a feature intended to delay the release of medication until it reaches the small intestine. Because these tablets are only standard coated, they may dissolve sooner than expected, which could potentially lead to stomach irritation for users who specifically require enteric-coated formulations.

What You Should Do

  1. Check your medicine cabinet for 50-count bottles of Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer labeled as 'Enteric Coated' with NDC 46122-649-71.
  2. Locate the lot number and expiration date on the side of the bottle to see if it matches Lot # P120999 with an expiration date of 07/31/2022.
  3. If you have the affected product, contact your healthcare provider or pharmacist for guidance regarding your medication needs.
  4. Return any unused bottles to the pharmacy or place of purchase for a full refund.
  5. Contact the manufacturer, LNK International, Inc., at their Hauppauge, NY location for any specific questions regarding this recall.
  6. For further information or to report a problem, 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

Healthcare consultation and refund.

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

Affected Products

Product: Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer (50 Coated Tablets/ 500 mg each)
Model:
NDC 46122-649-71
Recall #: D-0665-2021
Lot Numbers:
P120999 (Exp 07/31/2022)
Date Ranges: 07/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88244
Status: Resolved
Manufacturer: LNK International, Inc.
Sold By: Amerisource Bergen
Manufactured In: United States
Units Affected: 8,472 bottles
Distributed To: Pennsylvania

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.