Gabapentin Capsule
FDA Recall NDC 0904-6665
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Gabapentin (NDC 0904-6665). A significant event, classified as Class II, was initiated on Oct 10, 2025 by Major Pharmaceuticals. The reported reason for this action was: "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity ."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
October 2025 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Oct 10, 2025
Oct 29, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97777
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
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
0904-6665-61Product
0904-6666-61Product
0904-6667-61Product
October 2025 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Oct 10, 2025
Oct 29, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97777
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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).
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.
Affected Packages Involved in this Recall
0904-6665-61Product
0904-6666-61Product
0904-6667-61Product
55154-3363-0Product
55154-7992-0Product
55154-7993-0Product
June 2025 Class II Recall: Defective container; blister packaging inadequately sealed.
Recall Number
Class II Ongoing
Defective container; blister packaging inadequately sealed.
Jun 19, 2025
Jul 09, 2025
23,232 cartons
Recall Profile & Regulatory Data
Event ID
97087
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Batch or Lot Expiration Information
Lot# M05205, Exp Date 10/2026
Affected Packages Involved in this Recall
0904-6665-61Product
0904-6666-61Product
0904-6667-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
