Recall Enforment Report D-0508-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by The Harvard Drug Group LLC, originally initiated on 06-19-2025 for the 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 The product was recalled due to defective container; blister packaging inadequately sealed.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0508-202506-19-202507-09-2025Class II3,527 bagsGabapentin 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 55154-3363-0Defective container; blister packaging inadequately sealed.Ongoing
D-0507-202506-19-202507-09-2025Class II23,232 cartonsGabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61Defective container; blister packaging inadequately sealed.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0904-6665Gabapentin GabapentinCapsuleOralMajor PharmaceuticalsHuman Prescription Drug
0904-6666Gabapentin GabapentinCapsuleOralMajor PharmaceuticalsHuman Prescription Drug
0904-6667Gabapentin GabapentinCapsuleOralMajor PharmaceuticalsHuman Prescription Drug
55154-3363Gabapentin GabapentinCapsuleOralCardinal Health 107, LlcHuman Prescription Drug
55154-7992Gabapentin GabapentinCapsuleOralCardinal Health 107, LlcHuman Prescription Drug
55154-7993Gabapentin GabapentinCapsuleOralCardinal Health 107, LlcHuman Prescription Drug