FDAFDA · Food and drugs·Recall number D-0030-2026
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
Published October 29, 2025 · Recall initiated: October 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
What to do
Voluntary: Firm initiated
Recall details
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Distributor
- US Nationwide.
- Lot
- Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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