Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydrocortisone and Acetic Acid Otic Solution Recalled by Akorn Inc Due to Sub Potent Drug: OOS results observed for 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, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
Quantity: 15,322 10 ml bottles
Why Was This Recalled?
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Akorn Inc
Akorn Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report