November 2024 FDA Recall Esomeprazole Magnesium by Zydus Pharmaceuticals (usa) Inc (D-0102-2025 - Labeling)
This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on November 14, 2024 for the product Esomeprazole Magnesium. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0102-2025
Labeling: Not Elsewhere Classified - Wrong NDC number
11-14-2024
12-11-2024
4404 packs
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.
Zydus Pharmaceuticals (USA) 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.
USA Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Batch or Lot Expiration Information
Lot# : M408002, Exp 05/31/2026
