Recalls / Class II
Class IID-0031-2026
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).
- Brand name
- Gabapentin
- Generic name
- Gabapentin
- Active ingredient
- Gabapentin
- Route
- Oral
- NDCs
- 0904-6665, 0904-6666, 0904-6667, 55154-3363, 55154-7992, 55154-7993
- FDA application
- ANDA090858
- Affected lot / code 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.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recalling firm
- Firm
- The Harvard Drug Group LLC
- Manufacturer
- Major Pharmaceuticals
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, Dublin, Ohio 43017-1091
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-10-17
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0031-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.