Drug FDA Class III Ongoing Mislabeling

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

West-Ward Columbus Inc Published Jan 15, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact West-Ward Columbus Inc or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

Affected products (1)

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

METHADONE HYDROCHLORIDE · 2591 100-count boxes

NDC: 0054-0709, 0054-0710, 0054-0709-25, 0054-0709-20, 0054-0710-25, 0054-0710-20

Lot codes: AC2556A

Code info: Lot # AC2556A; Exp. 03/2027

Affected areas

Nationwide

Timeline

Initiated

Dec 19, 2024
Published

Jan 15, 2025

Recall number: D-0183-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.