Recalls / Class III
Class IIID-0102-2025
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
- Brand name
- Esomeprazole Magnesium
- Generic name
- Esomeprazole Magnesium
- Active ingredient
- Esomeprazole Magnesium Dihydrate
- Route
- Oral
- NDCs
- 68382-848, 68382-849
- FDA application
- ANDA206055
- Affected lot / code info
- Lot#: M408002, Exp 05/31/2026
Why it was recalled
Labeling: Not Elsewhere Classified - Wrong NDC number
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 4404 packs
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2024-11-14
- FDA classified
- 2024-12-04
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0102-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.