Use cautionDrug recall · FDA · Published January 4, 2024
Glenmark Recalls Fluocinolone Acetonide Ear Drops Due to Failed Assay
Glenmark recalls specific lots of Fluocinolone Acetonide Oil ear drops because the isopropyl alcohol assay failed specifications. Check your lot numbers.
Glenmark Pharmaceuticals Inc., USA is recalling Fluocinolone Acetonide Oil, 0.01% (Ear Drops) because the product failed excipient specifications for the assay of Isopropyl Alcohol. The recall affects 38,496 bottles distributed nationwide in the USA. This is a Class II recall. Read more at govinfonow.com/recall/32892-glenmark-recalls-fluocinolone-acetonide-ear-drops-due-to-failed-assay.
“Glenmark Recalls Fluocinolone Acetonide Ear Drops Due to Failed Assay.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32892-glenmark-recalls-fluocinolone-acetonide-ear-drops-due-to-failed-assay. Based on FDA recall #D-0259-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0259-2024%22&limit=1).
Glenmark Pharmaceuticals Inc., USA recalled Fluocinolone Acetonide Ear Drops on Jan. 4, 2024, after the FDA announced the product failed excipient specifications for Isopropyl Alcohol assay. The Food and Drug Administration issued the Class II recall.
The recall was initiated because the product failed excipient specifications, specifically showing out-of-specification results for the assay of Isopropyl Alcohol. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since Nov. 20, 2017. Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (Dec. 30, 2025), Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), and Shoolin Pharma Chem Sildenafil Recall (Aug. 3, 2026).
How to tell if you have this one
Check your bottle for NDC 68462-185-56 and look for one of these lot numbers: 05220346, 05220369, 05220582, or 05220861. The product is packaged in a 1 Oz. (20 mL fill volume) bottle and is Rx only.
Brand
Glenmark Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Lot Numbers
Compare the lot number on your bottle against the recalled lots: 05220346, 05220369, 05220582, and 05220861.
Contact Your Pharmacist
If you have a recalled lot, contact the pharmacy where you purchased the medication for instructions on return or replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0259-2024 (January 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0259-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.