Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluocinolone Acetonide Oil Recalled by Glenmark Pharmaceuticals Inc., USA Due to Failed Excipient Specifications: OOS for assay of Isopropyl...
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 Glenmark Pharmaceuticals Inc., USA directly.
Affected Products
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Quantity: 38,496 bottles
Why Was This Recalled?
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report