Esomeprazole Magnesium for Delayed-Release Oral Suspension — Class II drug recall D-0442-2025
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-05-28, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual un
| Recall number | D-0442-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-05-13 |
| Classified | 2025-05-20 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68382-0848, 68382-0848-94, 68382-0849, 68382-0849-94 |
| Lot numbers | M311638, M400374, M402496, M407998, M414512, M414770, M502247 |
| Expiration dates | 2025-07, 2025-10, 2026-02, 2026-05, 2026-09, 2026-11 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0442-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.