Medications & Supplements/Prescription Drugs

Oseltamivir Phosphate Oral Suspension Recalled for Failed Impurity Tests

Agency Publication Date: February 16, 2024

Summary

Amneal Pharmaceuticals of New York, LLC is recalling 46,037 bottles of Oseltamivir Phosphate for Oral Suspension (6mg/ml, 60 mL reconstituted bottle). This prescription flu medication (generic Tamiflu) is being recalled because testing revealed impurities and degradation products that exceeded approved safety specifications. The recall includes two specific lots distributed nationwide with NDC 69238-1273-6.

Risk

Using medication that has degraded or contains impurities beyond approved limits may result in reduced effectiveness or the ingestion of unintended chemical byproducts. No specific injuries or adverse health events have been reported in the recall data.

What You Should Do

This recall affects Oseltamivir Phosphate for Oral Suspension 6mg/ml (60 mL reconstituted bottle) distributed by Amneal Pharmaceuticals with NDC 69238-1273-6.
Identify affected bottles by checking for lot number BF22722A (expiration 08/31/2024) or lot number BJ15122A (expiration 09/30/2024).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oseltamivir Phosphate for Oral Suspension (60 mL)

Variants: 6mg/ml, 60 mL (reconstituted) bottle, RX only

Lot Numbers:

BF22722A (Exp. 08/31/2024)

BJ15122A (Exp. 09/30/2024)

NDC:

69238-1273-6

Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93959

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 46,037 Bottles

Distributed To: Nationwide

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 · 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

This recall affects Oseltamivir Phosphate for Oral Suspension 6mg/ml (60 mL reconstituted bottle) distributed by Amneal Pharmaceuticals with NDC 69238-1273-6.

Identify affected bottles by checking for lot number BF22722A (expiration 08/31/2024) or lot number BJ15122A (expiration 09/30/2024).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.