← FDA ENFORCEMENT
D-0031-2026Class II

The Harvard Drug Group LLC

Recalling firm
The Harvard Drug Group LLC
Product type
Drug
Status
Ongoing
Report date
2025-10-29
Distribution
US Nationwide.
Firm state
OH
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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).

Code / lot info

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.

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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.