Recalls / Class III
Class IIID-0183-2025
Product
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
- Brand name
- Methadone Hydrochloride
- Generic name
- Methadone Hydrochloride
- Active ingredient
- Methadone Hydrochloride
- Route
- Oral
- NDCs
- 0054-0709, 0054-0710
- FDA application
- ANDA088109
- Affected lot / code info
- Lot # AC2556A; Exp. 03/2027
Why it was recalled
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Recalling firm
- Firm
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 2591 100-count boxes
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-12-19
- FDA classified
- 2025-01-03
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0183-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.