FDA Drugs recall ·
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets… recall
Read the official FDA notice ↗
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
Why was it recalled?
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # AC2556A; Exp. 03/2027
Distribution
US Nationwide.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0183-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.