Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Acetic Acid Otic Solution Recalled by Hi-Tech Pharmacal Co., Inc. Due to Subpotent Drug: The product/lot is out-of-specification (OOS) for...
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 Hi-Tech Pharmacal Co., Inc. directly.
Affected Products
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Quantity: 11,472 bottles
Why Was This Recalled?
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hi-Tech Pharmacal Co., Inc.
Hi-Tech Pharmacal Co., Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report