Esomeprazole Magnesium for Delayed-Release Oral recall: Labeling Error
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
Why was Esomeprazole Magnesium for Delayed-Release Oral recalled?
Labeling: Not Elsewhere Classified - Wrong NDC number
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#: M408002, Exp 05/31/2026
- 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
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 4404 packs
- Distribution
- USA Nationwide.
- Recall date
- December 11, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)