Class II · ModerateActive recall
Gabapentin
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 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.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMajor Pharmaceuticals, Cardinal Health 107, LLC
| Brand name | GABAPENTIN |
| Generic name | GABAPENTIN |
| Active ingredient(s) | GABAPENTIN |
| Distributed by / for | Major Pharmaceuticals, Indianapolis, IN 46268, USA |
| NDC | 0904-6665-61 |
Show the full FDA record
| Full product label | 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). |
| Recalling firm | The Harvard Drug Group LLC |
| Distribution | US Nationwide. |
| Recall initiated | 2025-10-10 |
| Report date | 2025-10-29 |
| Recall completed | — |
| Recall number | D-0031-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Dublin OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.