Class IIIOngoing

Gabapentin Capsules recall

FDA recall D-0312-2025 · initiated Mar 4, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Cross Contamination

Details

Product: Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Recalling company: Sun Pharm Industries
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Mar 4, 2025
FDA report date: Apr 16, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0312-2025 ↗

← All drug recalls