FDA Recall D-0311-2025

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class III Ongoing 436 days on record

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

Product

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Lot / code: Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025

Quantity: 12,876 bottles

Reason for recall

Cross Contamination

Recall record

Recall number: D-0311-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-03-04
Classified by FDA Center: 2025-04-04
FDA published: 2025-04-16
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): GABAPENTIN
Generic name(s): GABAPENTIN
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 62756-137, 62756-138, 62756-139, 62756-202, 62756-204
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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