Gabapentin Tablet, Film Coated
FDA Recall NDC 70010-227
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gabapentin (NDC 70010-227). A significant event, classified as Class II, was initiated on Jul 31, 2024 by Granules Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2024 Class II Recall: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Recall Number
Class II Terminated
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Jul 31, 2024
Aug 14, 2024
11,808 500-count Bottles
Recall Profile & Regulatory Data
Event ID
95072
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 12, 2025
Product Description
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
70010-227-01Product
70010-227-05Product
70010-228-01Product
70010-228-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
