December 2024 FDA Recall Methadone Hydrochloride by West-ward Columbus Inc
D-0183-2025 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by West-ward Columbus Inc on December 19, 2024 for the product Methadone Hydrochloride. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0183-2025
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
12-19-2024
01-15-2025
2591 100-count boxes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-Ward Columbus Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# AC2556A; Exp. 03/2027
