Multi-event October 2025 FDA Recall Gabapentin by The Harvard Drug Group Llc
This Multi-event Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc on October 10, 2025 for the product Gabapentin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0030-2026
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
10-10-2025
10-29-2025
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The Harvard Drug Group LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
Recall Number: D-0031-2026
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
10-10-2025
10-29-2025
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The Harvard Drug Group LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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).
Batch or Lot Expiration Information
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.
