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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/Prescription Drugs

American Health Packaging Indomethacin Capsules Recalled for cGMP Deviations

Agency Publication Date: June 2, 2025
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Summary

Amerisource Health Services LLC is recalling 21 cartons of Indomethacin Extended-Release Capsules (75 mg), distributed by American Health Packaging, due to deviations from current Good Manufacturing Practice (cGMP) standards. The product is an outpatient prescription medication sold in cartons containing 30 capsules (three blister cards of 10 capsules each). Patients using this medication should contact their healthcare provider or pharmacist to discuss their treatment and how to obtain a replacement.

Risk

Manufacturing deviations mean the medication was not produced under strictly controlled conditions required by the FDA, which can impact the safety, quality, or purity of the drug. No injuries or adverse health effects have been reported in relation to this recall.

What You Should Do

  1. This recall affects Indomethacin Extended-Release Capsules, USP, 75 mg, distributed by American Health Packaging in cartons containing three 10-count blister cards.
  2. Identify the affected product by checking the carton for NDC 68084-411-21 or the individual blister cards for NDC 68084-411-11, specifically looking for lot number 1021950 with an expiration date of 11/30/2026.
  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 Amerisource Health Services LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Indomethacin Extended-Release Capsules, USP (75 mg)by American Health Packaging
Variants: 75 mg, 30 capsules per carton, 3 x 10 blister cards
Lot Numbers:
1021950 (Exp. 11/30/2026)
NDC:
68084-411-21
68084-411-11

Distributed by American Health Packaging

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96898
Status: Active
Manufacturer: Amerisource Health Services LLC
Sold By: American Health Packaging
Manufactured In: United States
Units Affected: 21 cartons
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.