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Class II · ModerateRecall completed

Extended Phenytoin Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # HM03221A, Exp. date 12/31/2023
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals LLC
Brand nameEXTENDED PHENYTOIN SODIUM
Generic namePHENYTOIN SODIUM
Active ingredient(s)PHENYTOIN SODIUM
Distributed by / forAmneal Pharmaceuticals LLC Bridgewater, NJ, 08807
NDC65162-212-10
Show the full FDA record
Full product labelExtended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionNationwide in the USA and Puerto Rico
Quantity9,263 100-count bottles
Recall initiated2023-10-27
Report date2023-11-15
Recall completed2025-08-06
Recall numberD-0090-2024
ClassificationClass II
FDA statusTerminated
Origin on fileBrookhaven NY United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.