FDA-Drug2026-01-07Class IIIPACKAGING DEFECT
Zydus trazodone 100mg tablets recalled for surface defects
What this means
Zydus Pharmaceuticals is recalling certain bottles of trazodone 100mg tablets because some tablets have dents on the surface. The defect affects lot EA00237A with an expiration date of 04/30/2027. No injuries have been reported.
- Check your trazodone bottle for lot number EA00237A
- Look at your tablets for dents or surface damage
- If your tablets match the affected lot, contact your pharmacist or doctor before taking any more doses
- Do not flush or throw away medication; ask your pharmacist how to safely dispose of it
The agency's original wording
Hazard
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
2,136 1000-count bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2026Want us to check the next one for you?
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