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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

Acetaminophen Tablets Distributed by Amazon Recalled for Discoloration

Agency Publication Date: June 17, 2025
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Summary

Aurobindo Pharma USA Inc is recalling 4,608 bottles of Acetaminophen (325 mg) because some tablets have shown brown surface discoloration. These 100-count bottles were distributed by Amazon.com Services LLC. The recall follows consumer complaints about the appearance of the tablets, which indicates deviations from required manufacturing quality standards.

Risk

Discolored tablets suggest the medication was not manufactured according to required quality standards, which could potentially impact the safety or effectiveness of the drug. While no injuries have been reported, the presence of brown spots on the tablets' surface is an indicator of product degradation or contamination.

What You Should Do

  1. This recall involves 100-count bottles of Acetaminophen Tablets (325 mg) distributed by Amazon.com Services LLC with NDC 72288-405-10.
  2. Check your bottle's packaging for lot number AEF124004A and an expiration date of 08/31/2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aurobindo Pharma USA Inc for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Acetaminophen Tablets, 325 mg, 100-count bottlesby Amazon.com Services LLC
Variants: 325 mg, 100-count bottles, Tablet
Lot Numbers:
AEF124004A (Exp 08/31/2026)
NDC:
72288-405-10

Distributed by Amazon.com Services LLC; Quantity: 4,608 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96907
Status: Active
Manufacturer: Aurobindo Pharma USA Inc
Sold By: Amazon.com
Manufactured In: United States
Units Affected: 4,608 bottles
Distributed To: Nationwide

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.