Pregabalin Capsule
FDA Recall NDC 64980-415
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 Pregabalin (NDC 64980-415). A significant event, classified as Class III, was initiated on May 16, 2024 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
May 16, 2024
Jun 12, 2024
N/A
Recall Profile & Regulatory Data
Event ID
94642
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Rising Pharma Holding, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Batch or Lot Expiration Information
Lot# Lot: 23132611, Exp 07/31/2026
Affected Packages Involved in this Recall
64980-410-09Product
64980-410-10Product
64980-410-01Product
64980-411-09Product
64980-411-10Product
64980-411-01Product
64980-412-09Product
64980-412-10Product
64980-412-01Product
64980-413-09Product
64980-413-10Product
64980-413-01Product
64980-414-09Product
64980-414-10Product
64980-414-01Product
64980-415-09Product
64980-415-10Product
64980-415-01Product
64980-416-09Product
64980-416-10Product
64980-416-01Product
64980-417-09Product
64980-417-10Product
64980-417-01Product
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.
