PlainRecalls
FDA Drug Moderate Class II Ongoing

Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.

Reported: April 16, 2025 Initiated: March 13, 2025 #D-0320-2025

Product Description

Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.

Reason for Recall

CGMP Deviations

Details

Units Affected
N/A
Distribution
U.S. Nationwide
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: N/A.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0320-2025.