FDARecalled Oct 29, 2025 · #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
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Classification: Class II Distribution: US Nationwide.
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- The Harvard Drug Group LLC
- Model numbers
- M04950, M04989, M05056, M05150, M05290, M05312, M05369
- UPCs
- —