FDA recall D-0183-2025

West-Ward Columbus Inc · Class III · drug

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.

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-12-19
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0183-2025