July 2024 FDA Recall Gabapentin by Granules Pharmaceuticals Inc.
D-0634-2024 - Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

This Class II drug recall was voluntarily initiated by Granules Pharmaceuticals Inc. on July 31, 2024 for the product Gabapentin. The FDA reported the reason for recall as presence of foreign tablets; 3 fused tablets of metformin er 500 mg were found in bottle of gabapentin tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0634-2024

Reason for Recall
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Initiated
07-31-2024
Reported
08-14-2024
Quantity
11,808 500-count Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95072
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Granules Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-12-2025
Product Description About Product Description
Full technical description of the product.
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

Batch or Lot Expiration Information

Lot# Lot 1380040A, Exp. date July 31, 2025

Affected Packages Involved in this Recall

70010-227-01 Gabapentin
70010-227-05 Gabapentin
70010-228-01 Gabapentin
70010-228-05 Gabapentin