Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Dis...
FDA Recall #D-0030-2026 — Class II — October 10, 2025
Product Description
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recalling Firm
The Harvard Drug Group LLC — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
US Nationwide.
Code Information
Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated