Reported Jan 7, 2026 · Ongoing
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,…
Zydus Pharmaceuticals (USA) Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only
- Manufactured byZydus Lifesciences Ltd., India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
- Lot codes and dates
- Lot # EA00237A
- Exp Date04/30/2027
- Amount recalled
- 2,136 1000-count bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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