FDAFDA · Food and drugs·Recall number D-0031-2026
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).
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.
- UPC
- 0055154336307
- Lot
- Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.