CLASS II Drug recall · Reported 22 Nov 2017 · FDA Enforcement Report

Fosphenytoin Sodium Injection, USP, 500 mg PE recalled

Amneal Pharmaceuticals is recalling Fosphenytoin Sodium Injection, USP, 500 mg PE/ (50 mg PE/mL. Single Dose Vial, distributed in Mississippi, North Carolina, Ohio, Texas, Utah. The recall was initiated on 31 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # AP160016; Exp. 05/18

Quantity recalled14,000 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0076-2018
FDA event ID: 78035
Recalling firm: Amneal Pharmaceuticals, Glasgow, KY
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2017
FDA classified: 13 Nov 2017
Reported: 22 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

31 Aug 2017	Recall initiated by company
13 Nov 2017	Classified by FDA	+74 days
22 Nov 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter

Product as listed by the FDA

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

Where it was distributed

MS, NC, OH, TX, UT

Mississippi North Carolina Ohio Texas Utah

Questions about this recall

Why was it recalled?

Presence of Particulate Matter

Which lots are affected?

Lot # AP160016; Exp. 05/18

Where was it sold?

MS, NC, OH, TX, UT

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Fosphenytoin recalls

All 6

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018Drug	CLASS II	Fosphenytoin Sodium Injection, USP 500 mg PE* recalled	Amneal Pharmaceuticals	Particulate Matter	Nationwide
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Aug 2012Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide
8 Aug 2012Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide