FDA recall, , Moderate risk
Teva Trazodone Hydrochloride Tablets
TraZODone Hydrochloride Tablets contain foreign tablets or capsules.
Summary by Recall Canary from the FDA notice
What happened
Teva Pharmaceuticals USA, Inc., of Parsippany, New Jersey, is recalling traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, because of the presence of foreign tablets or capsules. The recalled product was manufactured in Croatia by Pliva Hrvatska d.o.o, Zagreb, Croatia, and distributed nationwide in the U.S.
The recall began August 24, 2026, and was added to the FDA's Enforcement Report on September 2, 2026. The company initiated the recall of 175,392 bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
traZODone Hydrochloride Tablets, USP, 50 mg
- NDC
- 50111-560-01
- Lot code
- 1394026
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Teva Pharmaceuticals USA, IncParsippany, New Jersey
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99734
- Recall number
- D-0834-2026
- Quantity recalled
- 175,392 bottles
All recalls from Teva Pharmaceuticals USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
