FDA Drugs recall ·
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets… recall
- Recall number
- D-0834-2026
- Date
- (initiated August 24, 2026)
- Company / brand
- Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 175,392 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Foreign Tablets/Capsules
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 1394026, Exp. 02/2028.
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0834-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.