Akorn Recalls Hydrocortisone Ear Drops Due to Low Potency
Akorn recalls 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to subpotent drug levels. Check your lot number.
Use caution until it’s fixed
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Contact the company
What happened, in plain English
Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because the hydrocortisone content is lower than specified. This means the medication may not work effectively to treat ear infections or inflammation. The recall affects a specific lot distributed nationwide. Read more at govinfonow.com/recall/37652-akorn-recalls-hydrocortisone-ear-drops-due-to-low-potency.
Source Summary by GovInfoNow · govinfonow.com/recall/37652-akorn-recalls-hydrocortisone-ear-drops-due-to-low-potency · Updated October 11, 2026 · FDA enforcement record: FDA #D-0839-2020
Cite this page
“Akorn Recalls Hydrocortisone Ear Drops Due to Low Potency.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37652-akorn-recalls-hydrocortisone-ear-drops-due-to-low-potency. Based on FDA recall #D-0839-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0839-2020%22&limit=1).
Why it’s dangerous
The product has out-of-specification assay results, meaning it is subpotent. This reduces the likelihood of therapeutic success, potentially allowing an ear infection or inflammation to persist or worsen due to lack of effective medication.
Who’s affected
Patients who have been prescribed this specific otic solution by a healthcare provider. Individuals using the affected lot may receive inadequate treatment for their condition.
How to tell if you have this one
Look for a 10 mL dropper bottle labeled 'Hydrocortisone and Acetic Acid Otic Solution, USP'. Check for NDC 50383-901-10 and Lot #364667 with an expiration date of 12/20/2019. The manufacturer is Akorn, Inc., formerly associated with Hi-Tech Pharmacal Co., Inc.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches NDC 50383-901-10 and Lot #364667.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to discuss replacing the medication if you have the recalled lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years 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.
Questions people ask
Where was this product sold?
It was distributed nationwide in the USA and Puerto Rico.
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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-0839-2020 (December 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0839-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.