FDA Recall D-0031-2026

The Harvard Drug Group LLC · Dublin, OH

Class II Ongoing 216 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).

Lot / code: Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.

Reason for recall

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Recall record

Recall number: D-0031-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: US Nationwide.
Recall initiated: 2025-10-10
Classified by FDA Center: 2025-10-17
FDA published: 2025-10-29
Recalling firm: The Harvard Drug Group LLC
Firm location: Dublin, OH

Drug identification

Brand name(s): GABAPENTIN
Generic name(s): GABAPENTIN
Manufacturer(s): Major Pharmaceuticals, Cardinal Health 107, LLC
NDC(s): 0904-6665, 0904-6666, 0904-6667, 55154-3363, 55154-7992, 55154-7993
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

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

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