Class IIDrug
traZODone Hydrochloride Tablets recall
Summary
Teva Pharmaceuticals USA, Inc is recalling traZODone Hydrochloride Tablets (drug). According to the FDA report, the reason is: Presence of Foreign Tablets/Capsules. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- 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
- Reason
- Presence of Foreign Tablets/Capsules
- Lot / code info
- Lot: 1394026, Exp. 02/2028.
- Quantity
- 175,392 bottles
- Distribution
- U.S. Nationwide
- Recalling company
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ United States
- Recall started
- August 24, 2026
- FDA report date
- September 9, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0834-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Teva Pharmaceuticals USA, Inc) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.