FDA Drugs recall ·
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only… recall
- Recall number
- D-0508-2025
- Date
- (initiated June 19, 2025)
- Company / brand
- The Harvard Drug Group LLC
7000 Cardinal Pl, Dublin, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,527 bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Defective container; blister packaging inadequately sealed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# M05205A and M05205B, Exp Date 10/2026.
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0508-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.