⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

The Harvard Drug Group LLC: Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indiana

DrugsSource: FDA (drug) · Date: 2025-10-29

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for The Harvard Drug Group

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
The Harvard Drug Group LLC
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
Reason / hazard
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-10-10
Code info
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.
Voluntary mandated
Voluntary: Firm initiated
City
Dublin
State
OH
Country
United States
Event id
97777
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.