---
title: "Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... — FDA record D-0876-2023 | Is It on Recall"
description: "Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)"
url: https://isitonrecall.com/recall/fda-drug-d-0876-2023-extended-phenytoin-sodium-capsules-usp-100-mg-rx-only-100-capsules-per-bottle-distributed-by-amneal/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuti... — FDA record D-0876-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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.
- **Reason**: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- **Classification**: Class II
- **Recalling firm**: Amneal Pharmaceuticals of New York, LLC
- **Quantity**: 9,056 bottles
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0876-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0876-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # HL00721A, Exp. 12/2023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

LA, PA and OH.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)

## Dates in the source

- **Report date**: Jun 21, 2023
- **Recall initiation date**: May 30, 2023
- **Center classification date**: Jun 15, 2023
- **Termination date**: Jun 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0876-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Amneal Pharmaceuticals of New York, LLC records](https://isitonrecall.com/brand/amneal-pharmaceuticals-of-new-york-llc/)