Hill Derm recalls DermOtic Oil Ear Drops due to broken glass hazard
Hill Dermaceuticals recalls specific lots of DermOtic Oil ear drops because broken glass may be present in the dropper pipette. Check your lot numbers.
Stop using this now
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Contact the company
What happened, in plain English
Hill Dermaceuticals, Inc. is recalling DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops in 20 mL bottles due to a potential foreign substance hazard. The specific risk is the presence of broken glass within the glass pipette of the dropper. The recall covers multiple lots distributed nationwide. Read more at govinfonow.com/recall/36130-hill-derm-recalls-dermotic-oil-ear-drops-due-to-broken.
Source Summary by GovInfoNow · govinfonow.com/recall/36130-hill-derm-recalls-dermotic-oil-ear-drops-due-to-broken · Updated October 10, 2026 · FDA enforcement record: FDA #D-0637-2021
Cite this page
“Hill Derm recalls DermOtic Oil Ear Drops due to broken glass hazard.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36130-hill-derm-recalls-dermotic-oil-ear-drops-due-to-broken. Based on FDA recall #D-0637-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0637-2021%22&limit=1).
Why it’s dangerous
The hazard involves potential broken glass inside the glass pipette of the dropper. If used, this foreign substance could cause physical injury to the ear canal or surrounding tissue.
Who’s affected
Individuals who have purchased or received DermOtic Oil ear drops from the specified lots between manufacture and expiration dates listed in the record. Users are at risk of injury if broken glass is present in the dropper.
How to tell if you have this one
Check your bottle for the brand name DermOtic Oil and the NDC number 68791-103-20. Verify if your lot number matches one of the following: 19K036D, 19L039E, 20A001E, 20A003D, 20A003E, 20C013G, 20E025F, 20E025G, 20E025H, 20H041D, 20H041F, 20J043E, 20K050F, 20L055E, 21C015E, or 21C018E.
- Brand
Hill Dermaceuticals- Category
Drug
What to do — step by step
Stop using the product
Do not use the ear drops if you have any of the recalled lot numbers due to the risk of broken glass in the dropper.
Check your lot number
Compare the lot number on your bottle against the list provided in the recall record to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0637-2021 (May 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0637-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.