Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP Recalled by Taro Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Taro Pharmaceuticals Inc. directly.
Affected Products
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Quantity: 11,196 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Taro Pharmaceuticals Inc.
Taro Pharmaceuticals Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report