FDA Recall D-0183-2025
West-Ward Columbus Inc · Columbus, OH
Class III Ongoing 511 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Recall record
- Recall number
D-0183-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2024-12-19
- Classified by FDA Center
- 2025-01-03
- FDA published
- 2025-01-15
- Recalling firm
- West-Ward Columbus Inc
- Firm location
- Columbus, OH
Drug identification
- Brand name(s)
- METHADONE HYDROCHLORIDE
- Generic name(s)
- METHADONE HYDROCHLORIDE
- Manufacturer(s)
- Hikma Pharmaceuticals USA Inc.
- NDC(s)
0054-0709, 0054-0710- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.