Venlafaxine Tablets — Class II drug recall D-0310-2025
Completed recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-04-16, distributed nationwide. Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resemb
| Recall number | D-0310-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-03-21 |
| Classified | 2025-04-04 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| NDC | 68382-0018, 68382-0018-01, 68382-0018-05, 68382-0018-06, 68382-0018-10, 68382-0018-14, 68382-0018-16, 68382-0019, 68382-0019-01, 68382-0019-05, 68382-0019-06, 68382-0019-10, 68382-0019-14, 68382-0019-16, 68382-0020, 68382-0020-01, 68382-0020-05, 68382-0020-06, 68382-0020-10, 68382-0020-14, 68382-0020-16, 68382-0021, 68382-0021-01, 68382-0021-05, 68382-0021-06 and 10 more |
| Lot numbers | M314265 |
| Expiration dates | 2025-10-31 |
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 for recall
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
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-0310-2025. 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.