Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Product description
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).
Lot numbers, UPCs & expiration codes
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.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0031-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Oct 29, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC
Original FDA data
Every field from FDA enforcement report D-0031-2026, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97777
- Address
- 7000 Cardinal Pl
- Code information
- 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.
- Postal code
- 43017-1091
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0031-2026
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC
- Reason for recall
- Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Oct 10, 2025
- Center classification date
- Oct 17, 2025