FDA Drug recall D-0310-2025
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (…
- FDA Drug
- Class II
- completed
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (… by Zydus Pharmaceuticals Usa, citing presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0310-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-03-21 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Reason
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Identifiers
| ndc | 68382-018-06 |
|---|---|
| ndc | 68382-018-14 |
| ndc | 68382-018-16 |
| ndc | 68382-018-01 |
| ndc | 68382-018-05 |
| ndc | 68382-018-10 |
| ndc | 68382-019-06 |
| ndc | 68382-019-14 |
| ndc | 68382-019-16 |
| ndc | 68382-019-01 |
| ndc | 68382-019-05 |
| ndc | 68382-019-10 |
| ndc | 68382-020-06 |
| ndc | 68382-020-14 |
| ndc | 68382-020-16 |
| ndc | 68382-020-01 |
| ndc | 68382-020-05 |
| ndc | 68382-020-10 |
| ndc | 68382-021-06 |
| ndc | 68382-021-14 |
| ndc | 68382-021-16 |
| ndc | 68382-021-01 |
| ndc | 68382-021-05 |
| ndc | 68382-021-10 |
| ndc | 68382-101-06 |
| ndc | 68382-101-14 |
| ndc | 68382-101-16 |
| ndc | 68382-101-01 |
| ndc | 68382-101-05 |
| ndc | 68382-101-10 |
| code_info | Lot #: M314265, Exp.: 31 October 2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa
All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0310-2025%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.