Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg — Class III drug recall D-0102-2025
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2024-12-11, distributed nationwide. Labeling: Not Elsewhere Classified - Wrong NDC number
| Recall number | D-0102-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2024-11-14 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 4,404 packages |
| Reason classes | labeling |
| NDC | 68382-0848, 68382-0848-94, 68382-0849, 68382-0849-94 |
| Lot numbers | M408002 |
| Expiration dates | 2026-05-31 |
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
Reason for recall
Labeling: Not Elsewhere Classified - Wrong NDC number
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-0102-2025. 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.