Why it was recalled
Labeling: Not Elsewhere Classified - Wrong NDC number
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: M408002, Exp 05/31/2026
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0102-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 14, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 4404 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0102-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95767
- Address
- 73 Route 31 N
- Code information
- Lot#: M408002, Exp 05/31/2026
- Postal code
- 08534-3601
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0102-2025
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 4404 packs
- Reason for recall
- Labeling: Not Elsewhere Classified - Wrong NDC number
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Nov 14, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 4, 2024