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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: M314265, Exp.: 31 October 2025.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0310-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 21, 2025
- FDA report date
- Apr 16, 2025
- Quantity
- 13,128 100-Count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0310-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 96553
- Address
- 73 Route 31 N
- Code information
- Lot #: M314265, Exp.: 31 October 2025.
- Postal code
- 08534-3601
- Report date
- Apr 16, 2025
- Product type
- Drugs
- Recall number
- D-0310-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 13,128 100-Count Bottles
- Reason for recall
- Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Mar 21, 2025
- Initial firm notification
- Center classification date
- Apr 4, 2025