Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 42192-0614-05 recalled?

Phenytoin Sodium

Yes — this exact package was recalled

1 FDA recall names the code 42192-0614-05 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Phenytoin Sodium
Strength
PHENYTOIN SODIUM 50 mg/mL
Form
Injection · Intramuscular, Intravenous
Labeler
Acella Pharmaceuticals, LLC
Type
Human Prescription Drug
Product code
42192-0614

Recalls naming this package

Class III · Low risk

Phenytoin Sodium Injection

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

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-05 D-0070-2023
Class III · Low risk

Phenytoin Sodium Injection

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

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-02 D-0069-2023

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler