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 Subpotent Drug: Low Out of specification (OOS) assay...
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 dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Quantity: 16,078 bottles
Why Was This Recalled?
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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