Gabapentin Capsules recall: Impurity Out of Spec
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
Why was Gabapentin Capsules recalled?
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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
- Recalling firm
- The Harvard Drug Group LLC
- Distribution
- US Nationwide.
- Recall date
- October 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)