Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- Product
- traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
- Reason
- Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Dec 19, 2025
- Reported
- Jan 7, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 2,136 1000-count bottles
- Lot / codes
- Lot # EA00237A, Exp Date: 04/30/2027
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0247-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0247-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.