Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Lot numbers, UPCs & expiration codes
Lot: 1394026, Exp. 02/2028.
Where it was sold
U.S. 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-0834-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 24, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 175,392 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0834-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99734
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot: 1394026, Exp. 02/2028.
- Postal code
- 07054-1120
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0834-2026
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 175,392 bottles
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 8, 2026