D-0834-2026 Class II Ongoing

Recalled by Teva Pharmaceuticals USA, Inc — Parsippany, NJ

FDA drug recall D-0834-2026 was initiated by Teva Pharmaceuticals USA, Inc on August 24, 2026 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules The recall status is ongoing. Affected quantity: 175,392 bottles.

Recall Details

Product Type
Drugs
Report Date
September 9, 2026
Initiation Date
August 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
175,392 bottles

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

Reason for Recall

Presence of Foreign Tablets/Capsules

Distribution Pattern

U.S. Nationwide

Code Information

Lot: 1394026, Exp. 02/2028.