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Class III · Lower riskActive recall

Trazodone Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # EA00237A, Exp Date: 04/30/2027
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameTRAZODONE HYDROCHLORIDE
Generic nameTRAZODONE HYDROCHLORIDE
Active ingredient(s)TRAZODONE HYDROCHLORIDE
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC68382-806-10
Show the full FDA record
Full product labeltraZODONE 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
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide in the USA
Quantity2,136 1000-count bottles
Recall initiated2025-12-19
Report date2026-01-07
Recall completed—
Recall numberD-0247-2026
ClassificationClass III
FDA statusOngoing
Origin on filePennington NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.