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

FDA recall notice · announced January 15, 2025 · West-ward Columbus

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: US Nationwide.
Lot/code information: Lot # AC2556A; Exp. 03/2027
Quantity: 2591 100-count boxes
Status: Ongoing
Products in this recall event:
- 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 (D-0183-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.