The Harvard Drug Group LLC: Drug Recall
Recall #D-0031-2026 · 10/10/2025
Class II: Risk
Recall Details
- Recall Number
- D-0031-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC
- Status
- Ongoing
- Date Initiated
- 10/10/2025
- Location
- Dublin, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
Reason for Recall
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).
Distribution Pattern
US Nationwide.
Other Recalls by The Harvard Drug Group LLC
- Class II: Risk 10/10/2025
- Class II: Risk 06/19/2025
- Class II: Risk 06/19/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.