Medications & Supplements/Prescription Drugs

Taro Hydrocortisone Otic Solution Recalled for Failed Impurity Specifications

Agency Publication Date: November 6, 2023

Summary

Taro Pharmaceuticals Inc. is recalling 11,196 bottles of Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP (10ml dropper bottle), a prescription ear medication. The recall was issued because stability testing found levels of an impurity that did not meet quality standards, as well as a slightly lower-than-required amount of the active ingredient, hydrocortisone. No incidents or injuries have been reported to date in connection with this recall.

Risk

The product may contain degradation impurities or have reduced potency, which could make the medication less effective at treating the intended ear condition. No injuries have been reported.

What You Should Do

This recall affects 10ml dropper bottles of Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP labeled with NDC 51672-3007-1.
Identify if your product is affected by checking the lot number and expiration date printed on the bottle. The affected lots are AC86809 and AC86812 with an expiration date of 01/31/2024.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP (10ml dropper bottle)by Taro

Variants: 10ml dropper bottle, Otic Solution

Lot Numbers:

AC86809 (Exp 01/31/2024)

AC86812 (Exp 01/31/2024)

NDC:

51672-3007-1

RX Only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93337

Status: Resolved

Manufacturer: Taro Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: Canada

Units Affected: 11,196 bottles

Distributed To: Nationwide

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 10ml dropper bottles of Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP labeled with NDC 51672-3007-1.

Identify if your product is affected by checking the lot number and expiration date printed on the bottle. The affected lots are AC86809 and AC86812 with an expiration date of 01/31/2024.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.