← FDA ENFORCEMENT
D-0834-2026Class II

Teva Pharmaceuticals USA, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2026-09-09
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
175,392 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Code / lot info

Lot: 1394026, Exp. 02/2028.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →