Medications & Supplements/Prescription Drugs

Taro Pharmaceuticals U.S.A., Inc.: Phenytoin Oral Suspension Recalled Due to Resuspension Problems

Agency Publication Date: February 25, 2020

Summary

Taro Pharmaceuticals is voluntarily recalling 29,172 bottles of Phenytoin Oral Suspension USP (125 mg/5 mL), a prescription medication used to control seizures. The liquid medicine may coagulate (thicken) in the bottle, which prevents it from mixing properly when shaken as directed. If the medicine does not resuspend, patients may receive an incorrect dose, leading to either too much or too little medication in each spoonful.

Risk

If the drug coagulates and does not resuspend, the concentration of the medication can become uneven; this may result in a sub-therapeutic dose that fails to prevent seizures or a toxic dose that causes serious side effects.

What You Should Do

Check your medication bottle to see if it is Phenytoin Oral Suspension USP, 125 mg/5 mL in an 8 fl oz (237 mL) bottle with NDC 51672-4069-1.
Verify if your bottle belongs to one of the affected lots: Lot# 327874 or Lot# 327876, both with an expiration date of Dec/2020.
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to ensure your treatment is not interrupted.
Return any unused or affected medication to your pharmacy to receive a refund.
Contact Taro Pharmaceuticals U.S.A., Inc. at 1-888-723-3332 for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Phenytoin Oral Suspension USP, 125 mg/5 mL (8 fl oz / 237 mL)

Model:

NDC 51672-4069-1

Recall #: D-0863-2020

Lot Numbers:

327874 (Exp Dec/2020)

327876 (Exp Dec/2020)

Date Ranges: Expiration Dec/2020

Product Images

Product label, TARO Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237mL) Taro Pharmaceuticals U.S.A., Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84916

Status: Resolved

Manufacturer: Taro Pharmaceuticals U.S.A., Inc.

Sold By: pharmacies

Manufactured In: Israel, United States

Units Affected: 29,172 8 Fl Oz bottles

Distributed To: Nationwide

Agency Last Updated: March 2, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle to see if it is Phenytoin Oral Suspension USP, 125 mg/5 mL in an 8 fl oz (237 mL) bottle with NDC 51672-4069-1.

Verify if your bottle belongs to one of the affected lots: Lot# 327874 or Lot# 327876, both with an expiration date of Dec/2020.

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to ensure your treatment is not interrupted.

Return any unused or affected medication to your pharmacy to receive a refund.

Contact Taro Pharmaceuticals U.S.A., Inc. at 1-888-723-3332 for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.