Recalls / Class II
Class IID-0310-2025
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.
- Brand name
- Venlafaxine
- Generic name
- Venlafaxine
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 68382-018, 68382-019, 68382-020, 68382-021, 68382-101
- FDA application
- ANDA077653
- Affected lot / code info
- Lot #: M314265, Exp.: 31 October 2025.
Why it was recalled
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 13,128 100-Count Bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-03-21
- FDA classified
- 2025-04-04
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0310-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.