CLASS III Drug recall · Reported 30 Nov 2022 · FDA Enforcement Report

Phenytoin Sodium Injection, USP, 250 mg recalled

Acella Pharmaceuticals is recalling Phenytoin Sodium Injection, USP, 250 mg, distributed nationwide in the US. The recall was initiated on 14 Nov 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: E026A001 Exp. 06/2023

NDC42192-614

Quantity recalled637 cartons

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-0070-2023
FDA event ID: 91149
Recalling firm: Acella Pharmaceuticals, Alpharetta, GA
Brand: Phenytoin Sodium
Manufacturer: Acella Pharmaceuticals, LLC
Classification: Class III
Status: Terminated
Recall initiated: 14 Nov 2022
FDA classified: 23 Nov 2022
Reported: 30 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Injectable & IV Drugs

Timeline

14 Nov 2022	Recall initiated by company
23 Nov 2022	Classified by FDA	+9 days
30 Nov 2022	Published in enforcement report	+7 days

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

Reason for recall

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Which lots are affected?

Lot: E026A001 Exp. 06/2023

Where was it sold?

Nationwide in the USA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

Other products in this recall event

1 other product · FDA event 91149

Reported	Class	Recall	Company	Reason	Where
30 Nov 2022	CLASS III	Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide

More recalls from Acella Pharmaceuticals

All 16

Reported	Class	Recall	Company	Reason	Where
13 May 2026Drug	CLASS II	Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen	Acella Pharmaceuticals	Lead & Heavy Metals	Nationwide
15 Oct 2025Drug	CLASS II	Doxycycline Hyclate Tablets, USP 100 mg* recalledDoxycycline	Acella Pharmaceuticals	Potency & Assay	Nationwide
15 May 2024Drug	CLASS III	Sodium Sulfacetamide 10% - Sulfur 5% Cleanser recalledSodium Sulfacetamide 10 Sulfur 5 Cleanser	Acella Pharmaceuticals	Potency & Assay	Nationwide
7 Dec 2022Drug	CLASS III	Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads recalled	Acella Pharmaceuticals	Potency & Assay	Nationwide
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide

Other Phenytoin recalls

All 10

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Drug	CLASS I	Phenytoin Oral Suspension, USP, 100 mg recalled	The Harvard Drug Group	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
21 Jun 2023Drug	CLASS II	Extended Phenytoin Sodium Capsules, USP, 100 mg recalledExtended Phenytoin Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	LA, OH, PA
30 Nov 2022Drug	CLASS III	Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium	Acella Pharmaceuticals	Packaging Defects	Nationwide
4 Mar 2020Drug	CLASS I	Phenytoin Oral Suspension USP, 125 mg/ potency recalledPhenytoin	Taro Pharmaceuticals U	Potency & Assay	Nationwide