Prescription Drug Recall: Extended Phenytoin Sodium Dissolution Failure
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules (Lot HL00721A, Exp. 12/2023) due to failed dissolution specifications. The extended-release mechanism did not function properly, which could affect medication absorption.
What this means for you
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 is an FDA Class II recall involving a manufacturing defect in an antiepileptic drug with a narrow therapeutic window. Although no illnesses or injuries are reported, improper dissolution in an extended-release formulation represents a documented risk of harm to patients, meeting the criteria for High severity.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Extended Phenytoin Sodium (phenytoin sodium) Capsules, USP, 100 mg, due to failed dissolution specifications. Testing found that dissolution results exceeded specification limits, meaning the capsules dissolve faster than designed for the extended-release formulation.
Phenytoin is an antiepileptic medication designed to release slowly in the body over time. Extended-release formulations maintain steady medication levels in the bloodstream. When dissolution occurs faster than specified, the medication may be absorbed differently than intended.
The recall affects 9,056 bottles of Lot #HL00721A (Exp. 12/2023) distributed in Louisiana, Pennsylvania, and Ohio. Patients taking this medication should contact their pharmacist or healthcare provider to verify whether their bottles are from this affected lot.
Patients should not stop taking phenytoin without consulting their doctor, as suddenly stopping an antiepileptic medication can be harmful. Those with affected medication should contact their pharmacist or healthcare provider to arrange a replacement and discuss next steps.
The recalled product
- Product
- EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Hazard
- dissolution-failure
- formulation-defect
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 # HL00721A
- Exp. 12/2023
UPCs (2)
- 0365162212037
- 0365162212105
Distribution
Distributed in 3 states:
- LA
- OH
- PA
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