Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Product description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Lot numbers, UPCs & expiration codes
Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
Where it was sold
Nationwide -in the USA
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-0442-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 13, 2025
- FDA report date
- May 28, 2025
- Quantity
- 30,674 30 sachets/carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0442-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96860
- Address
- 73 Route 31 N
- Code information
- Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
- Postal code
- 08534-3601
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0442-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 30,674 30 sachets/carton
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Distribution pattern
- Nationwide -in the USA
- Recall initiation date
- May 13, 2025
- Initial firm notification
- Letter
- Center classification date
- May 20, 2025