Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles Recalled by Hill Dermaceuticals, Inc. Due to Presence of Foreign Substance: Potential for broken glass...
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 Hill Dermaceuticals, Inc. directly.
Affected Products
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Quantity: 34,561 bottles for sale; 773 bottles for samples
Why Was This Recalled?
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hill Dermaceuticals, Inc.
Hill Dermaceuticals, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report