GABAPENTIN
Recalling Firm / Manufacturer: The Harvard Drug Group LLC
(Dublin, OH, United States)
FDA Recall Number: D-0031-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
GABAPENTIN
Generic Name
GABAPENTIN
Active Substance(s)
Gabapentin
Administration Route
Oral
National Drug Code (NDC)
0904-6665
Total Quantity Recalled
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Full Product Description
Packaging specifications and labeling details
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).
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 29, 2025
Firm Initiation Date
October 10, 2025
FDA Classification Date
Oct 17, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
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.
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0031-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC