Amneal Pharmaceuticals Fosphenytoin Sodium Injection Recall

Why it was recalled

Presence of Particulate Matter

Product description

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

Lot numbers, UPCs & expiration codes

Lot # AP160016; Exp. 05/18

Where it was sold

MS, NC, OH, TX, UT

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0076-2018
Classification: Class II
Status: Terminated
Recall initiated: Aug 31, 2017
FDA report date: Nov 22, 2017
Quantity: 14,000 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Amneal Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-0076-2018, exactly as published.

Show all FDA fields

City: Glasgow
State: KY
Status: Terminated
Country: United States
Event ID: 78035
Address: 118 Beaver Trl
Code information: Lot # AP160016; Exp. 05/18
Postal code: 42141-1273
Report date: Nov 22, 2017
Product type: Drugs
Recall number: D-0076-2018
Classification: Class II
Recalling firm: Amneal Pharmaceuticals LLC
Product quantity: 14,000 vials
Termination date: Sep 10, 2019
Reason for recall: Presence of Particulate Matter
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: MS, NC, OH, TX, UT
Recall initiation date: Aug 31, 2017
Initial firm notification: Letter
Center classification date: Nov 13, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0076-2018, published Nov 22, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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