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, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Lot numbers, UPCs & expiration codes

Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018

Where it was sold

U.S.A Nationwide

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-0610-2018
Classification: Class II
Status: Terminated
Recall initiated: Dec 15, 2017
FDA report date: Apr 4, 2018
Quantity: 12,584 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Amneal Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0610-2018, exactly as published.

Show all FDA fields

City: Brookhaven
State: NY
Status: Terminated
Country: United States
Event ID: 79610
Address: 50 Horseblock Rd
Code information: Lot #: AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
Postal code: 11719-9509
Report date: Apr 4, 2018
Product type: Drugs
Recall number: D-0610-2018
Classification: Class II
Recalling firm: Amneal Pharmaceuticals
Product quantity: 12,584 vials
Termination date: Aug 3, 2020
Reason for recall: Presence of particulate matter
Voluntary / mandated: Voluntary: Firm initiated
Product description: Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Distribution pattern: U.S.A Nationwide
Recall initiation date: Dec 15, 2017
Initial firm notification: Letter
Center classification date: Mar 29, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0610-2018, published Apr 4, 2018. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.