Recalls / Class III
Class IIID-0247-2026
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
- Brand name
- Trazodone Hydrochloride
- Generic name
- Trazodone Hydrochloride
- Active ingredient
- Trazodone Hydrochloride
- Route
- Oral
- NDCs
- 68382-609, 68382-805, 68382-806, 68382-807, 68382-808, 68382-610
- FDA application
- ANDA205253
- Affected lot / code info
- Lot # EA00237A, Exp Date: 04/30/2027
Why it was recalled
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 2,136 1000-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-19
- FDA classified
- 2025-12-31
- Posted by FDA
- 2026-01-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0247-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.