Skip to content
Back to recalls
Drug FDA Class III Ongoing Quality

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

Zydus Pharmaceuticals (USA) Inc Published Jan 7, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

TRAZODONE HYDROCHLORIDE · 2,136 1000-count bottles

NDC: 68382-609, 68382-805, 68382-806, 68382-807, 68382-808, 68382-610, 68382-805-01, 68382-805-30, 68382-805-77, 68382-805-05, 68382-805-10, 68382-805-06, 68382-805-16, 68382-806-06, 68382-806-16, 68382-806-01, 68382-806-05, 68382-806-10, 68382-806-30, 68382-806-77, 68382-807-06, 68382-807-16, 68382-807-01, 68382-807-05, 68382-807-10, 68382-807-30, 68382-807-77, 68382-808-06, 68382-808-16, 68382-808-01, 68382-808-05, 68382-808-10, 68382-808-30, 68382-808-77, 68382-609-01, 68382-609-05, 68382-609-10, 68382-610-01, 68382-610-05, 68382-610-10
Lot codes: EA00237A
Code info: Lot # EA00237A, Exp Date: 04/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 19, 2025
  2. Published
    Jan 7, 2026
Recall number
D-0247-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.