Why it was recalled
Defective container; blister packaging inadequately sealed.
Product description
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Lot numbers, UPCs & expiration codes
Lot# M05205A and M05205B, Exp Date 10/2026.
Where it was sold
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-0508-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 19, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 3,527 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC
Original FDA data
Every field from FDA enforcement report D-0508-2025, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97087
- Address
- 7000 Cardinal Pl
- Code information
- Lot# M05205A and M05205B, Exp Date 10/2026.
- Postal code
- 43017-1091
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0508-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC
- Product quantity
- 3,527 bags
- Reason for recall
- Defective container; blister packaging inadequately sealed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 19, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2025