Prescription Drug Recalled Due to Failed Dissolution Specifications
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves failed dissolution specifications in a prescription medication, representing a risk-of-harm scenario where the drug may not be properly absorbed. No illnesses or injuries have been reported in the source text.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Extended Phenytoin Sodium Capsules, USP, 100 mg in 100-count bottles. Lot HM03221A (expiration date 12/31/2023) is affected. Approximately 9,263 bottles have been distributed nationwide throughout the United States and Puerto Rico.
The recall was initiated due to failed dissolution specifications. Dissolution specifications are standards that ensure tablets properly dissolve in the digestive system to allow drug absorption.
Patients and healthcare providers should be aware of this recall. For additional information or questions about this recall, contact the recalling manufacturer, Amneal Pharmaceuticals, or your healthcare provider.
The recalled product
- Product
- EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # HM03221A
- Exp. date 12/31/2023
UPCs (2)
- 0365162212037
- 0365162212105
Distribution
Related recalls
Same brand · EXTENDED PHENYTOIN SODIUM
- HighPrescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure
FDA (Drugs) · 2023-06-21
- ModerateAmneal Recalls Extended Phenytoin Sodium Capsules Due to Dissolution Failure
FDA (Drugs) · 2013-11-13
Same manufacturer · Amneal Pharmaceuticals of New York, LLC
See all →- HighAmneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
- HighMethylergonovine Maleate tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-05-08
- SevereVancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
FDA (Drugs) · 2024-04-24
- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- ModerateFDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities
FDA (Drugs) · 2024-02-28
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateAmneal Recalls Extended Phenytoin Sodium Capsules Due to Dissolution Failure
FDA (Drugs) · 2013-11-13
- HighPrescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure
FDA (Drugs) · 2023-06-21
- HighDivalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-08-31
- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- ModerateAmneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2017-05-10
- SevereAmneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
FDA (Drugs) · 2017-11-22