Fluocinolone Acetonide Oil recall
FDA recall D-0259-2024 · initiated Jan 4, 2024
Glenmark Pharmaceuticals Inc., USA recalled Fluocinolone Acetonide Oil in Jan 2024 — an FDA Class II recall (D-0259-2024) because Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 38,496 bottles
Details
- Product
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jan 4, 2024
- FDA report date
- Jan 31, 2024
Frequently asked
- Was Fluocinolone Acetonide Oil recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Fluocinolone Acetonide Oil in Jan 2024 — an FDA Class II recall (D-0259-2024) because Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fluocinolone Acetonide Oil recalled?
- Per the FDA enforcement record, the reason for recall D-0259-2024 was: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
- Is a recalled Fluocinolone Acetonide Oil dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluocinolone Acetonide Oil are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0259-2024.