Recalls / Class II

Class IID-0320-2025

Product

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.

Brand name: Gabapentin
Generic name: Gabapentin
Active ingredient: Gabapentin
Route: Oral
NDCs: 68462-126, 68462-127
FDA application: ANDA077662
Affected lot / code info: Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25

Why it was recalled

CGMP Deviations

Recalling firm

Firm: Glenmark Pharmaceuticals Inc., USA
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009

Distribution

Quantity: N/A
Distribution pattern: U.S. Nationwide

Timeline

Recall initiated: 2025-03-13
FDA classified: 2025-04-08
Posted by FDA: 2025-04-16
Status: Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0320-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.