FDA Recall D-0247-2026

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class III Ongoing 146 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot # EA00237A, Exp Date: 04/30/2027

Quantity: 2,136 1000-count bottles

Reason for recall

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

Recall record

Recall number: D-0247-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-12-19
Classified by FDA Center: 2025-12-31
FDA published: 2026-01-07
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): TRAZODONE HYDROCHLORIDE
Generic name(s): TRAZODONE HYDROCHLORIDE
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 68382-609, 68382-805, 68382-806, 68382-807, 68382-808, 68382-610
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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