Class II
Ongoing
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).
This recall is currently active, issued October 29, 2025. It was issued by The Harvard Drug Group Llc.
- Company
- The Harvard Drug Group Llc
- Recall Initiated
- October 10, 2025
- Posted
- October 29, 2025
- Recall Number
- D-0031-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Distribution
US Nationwide.
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.
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