Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hydrocortisone 1% & Acetic Acid 2% Otic Solution Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related...
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 U.S.A., Inc. directly.
Affected Products
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Quantity: 96 vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Where Was This Sold?
Product was distributed to one distributor
About Taro Pharmaceuticals U.S.A., Inc.
Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report