FDAClass IIIJanuary 15, 2025

Methadone Hydrochloride Tablets recall

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 Methadone Hydrochloride Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # AC2556A; Exp. 03/2027

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
Recalling firm
West-Ward Columbus Inc
Quantity
2591 100-count boxes
Distribution
US Nationwide.
Recall date
January 15, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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