Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hydrocortisone and Acetic Acid Otic Solution Recalled by Akorn, Inc. Due to Defective Container: Product missing safety seal around the...
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 Akorn, Inc. directly.
Affected Products
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Quantity: 13,896 bottles
Why Was This Recalled?
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report