Drug recall: Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC…

Class II FDA enforcement event 93292. Recall start date: 27 Oct 2023. Status in the FDA record: Terminated. Termination date: 6 Aug 2025.

Reason for recall, in the words of FDA

Failed Dissolution Specifications

Class II, in the words of FDA

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

Amneal Pharmaceuticals of New York, LLC started this drug recall on 27 Oct 2023. The firm address in the FDA record is in Brookhaven, NY. FDA put the recall in Class II. FDA event 93292 has 1 product record. The first FDA enforcement report date is 15 Nov 2023. The record gives the status Terminated, with the termination date 6 Aug 2025.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA and Puerto Rico

Recalling firm

Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 93292: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0090-2024	Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10	9,263 100-count bottles	Class II	Terminated	15 Nov 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class II: 59%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Amneal Pharmaceuticals of New York, LLC
Initiated	Product (first record)	Type	Class	Records
25 Mar 2024	Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bri	Drug	Class II	1
21 Mar 2024	Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15	Drug	Class I	1
13 Feb 2024	Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceu	Drug	Class II	1
15 Jan 2024	Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pv	Drug	Class II	1
26 Dec 2023	Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pv	Drug	Class II	1
30 May 2023	Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceutical	Drug	Class II	1
8 May 2023	Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injecti	Drug	Class III	1
27 Jul 2022	Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal	Drug	Class II	1
4 Nov 2021	Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals	Drug	Class II	2
29 May 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal	Drug	Class II	12

Amneal Pharmaceuticals of New York, LLC: all 14 events

Official channels

FDA enforcement report D-0090-2024The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 93292. https://recallregister.com/fda/ii/93292/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA and Puerto Rico
What quantity of product is in FDA event 93292?: The FDA record gives this quantity: 9,263 100-count bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2023 have the same class?: 59% of the 281 drug events that started in 2023 are in Class II.