Gabapentin Recall: Major Pharmaceuticals 100 mg capsules Rx only
Announced 2026-07-01 · FDA
The Harvard Drug Group LLC is recalling Gabapentin Capsules, USP, 100 mg, 100 capsules (Rx only) packaged and distributed by Major Pharmaceuticals in the United States. The recall is due to a failed impurities/degradation specification for Highest Unknown Impurity, an out-of-specification result from stability testing. The affected lots include M04950 (exp 01/2026); M04989 and M04990 (exp 02/2026); M05056 (04/2026); M05150 (07/2026); M05290 (11/2026); M05312 and M05342 (01/2027); M05369 and M05386 (02/2027); distributed nationwide.
| Brand | The Harvard Drug Group LLC |
|---|---|
| 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 |
| Reason | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . |
| Severity | moderate |
| Units affected | 790 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Do not use recalled Gabapentin capsules.
- Check your bottle's lot number and expiration date against the recalled lots; if it matches, stop using the product.
- Follow the recall instructions from the distributor (return or disposal) and obtain a replacement if offered.
- If you have health concerns, contact your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.