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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/Prescription Drugs

Methadone Hydrochloride Tablets Recalled for Illegible Identification

Agency Publication Date: January 4, 2025
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Summary

West-Ward Columbus Inc. is recalling 2,591 boxes of Methadone Hydrochloride (methadone) 5mg tablets because the product identification on the individual unit-dose packaging is illegible. The recall affects 100-count boxes containing 10 strips of 10 tablets distributed by Hikma Pharmaceuticals USA Inc. under lot number AC2556A. This recall only applies to the unit-dose configuration and not other packaging types.

Risk

If the identification on the individual unit-dose packaging is unreadable, patients or healthcare providers may be unable to verify the medication name or dosage strength. This could lead to potential medication errors or confusion during administration.

What You Should Do

  1. The recalled products are Methadone Hydrochloride Tablets, USP, 5mg, sold in 100-count boxes (10 strips of 10 unit-dose tablets) distributed by Hikma Pharmaceuticals USA Inc.
  2. Check your medication packaging for NDC 0054-0709-20, lot number AC2556A, and an expiration date of 03/2027.
  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 the manufacturer 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 a problem.

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: Methadone Hydrochloride Tablets, USP (5mg)
Variants: 5mg, 10x10 Unit-Dose Tablets, Tablet
Lot Numbers:
AC2556A (Exp. 03/2027)
NDC:
0054-0709-20

Recall affects the unit dose configuration only; distributed by Hikma Pharmaceuticals USA Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95999
Status: Active
Manufacturer: West-Ward Columbus Inc
Sold By: Hikma Pharmaceuticals USA Inc.
Manufactured In: United States
Units Affected: 2591 100-count boxes
Distributed To: Nationwide

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.