FDA Drug recall D-0102-2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd
- FDA Drug
- Class III
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class III recall of Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd by Zydus Pharmaceuticals Usa, citing labeling: Not Elsewhere Classified - Wrong NDC number.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0102-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-11-14 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Labeling: Not Elsewhere Classified - Wrong NDC number
Identifiers
| ndc | 68382-848-94 |
|---|---|
| ndc | 68382-849-94 |
| code_info | Lot#: M408002, Exp 05/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0102-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.