Extended Phenytoin Sodium Capsule
FDA Recall NDC 65162-212
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Extended Phenytoin Sodium (NDC 65162-212). A significant event, classified as Class II, was initiated on Oct 27, 2023 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Failed Dissolution Specifications"
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
Class II Terminated
Failed Dissolution Specifications
Oct 27, 2023
Nov 15, 2023
9,263 100-count bottles
Recall Profile & Regulatory Data
Event ID
93292
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Aug 06, 2025
Product Description
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Batch or Lot Expiration Information
Lot# HM03221A, Exp. date 12/31/2023
Affected Packages Involved in this Recall
65162-212-03Product
65162-212-10Product
65162-212-50Product
65162-212-11Product
Class II Terminated
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
May 30, 2023
Jun 21, 2023
9,056 bottles
Recall Profile & Regulatory Data
Event ID
92368
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
LA, PA and OH.
Termination Date
Jun 10, 2025
Product Description
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Batch or Lot Expiration Information
Lot# HL00721A, Exp. 12/2023
Affected Packages Involved in this Recall
65162-212-03Product
65162-212-10Product
65162-212-50Product
65162-212-11Product
August 2013 Class II Recall: Failed dissolution specifications; 18 month CRT
Recall Number
Class II Terminated
Failed dissolution specifications; 18 month CRT
Aug 17, 2013
Nov 13, 2013
895 - 1000 count bottles
Recall Profile & Regulatory Data
Event ID
66014
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, NH, NJ, NY, OH, RI, TN
Termination Date
Jul 17, 2014
Product Description
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Batch or Lot Expiration Information
Lot# Batch/Lot HL50611, exp. 1/2014
Affected Packages Involved in this Recall
65162-212-03Product
65162-212-10Product
65162-212-50Product
65162-212-11Product
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.
