Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC.,
Akorn recalls hydrocortisone otic solution with low hydrocortisone content due to lab test failure. This may not treat ear infections effectively. Consumers should contact pharmacy for guidance.
Lower-risk recall
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling hydrocortisone and acetic acid otic solution (ear drops) because lab tests showed lower-than-stated hydrocortisone levels. This means the product may not work well for ear infections as intended. Read more at govinfonow.com/recall/37652-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37652-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0839-2020
Cite this page
“Akorn Hydrocortisone Otic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37652-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk. 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 lower-than-stated hydrocortisone levels because lab tests found the hydrocortisone portion was out of specification. This means the solution may not provide the intended medical effect for ear infections.
Who’s affected
People who have the specific 10mL dropper bottle with lot number 364667 (expired 12/20/2019) from HI-TECH PHARMACAL CO., INC. in Amityville, NY. Those using this product for ear infections are most at risk of ineffective treatment.
How to tell if you have this one
Check for the 10mL dropper bottle with lot number 364667 (expired 12/20/2019) from HI-TECH PHARMACAL CO., INC. in Amityville, NY. The product is prescription-only and sold under NDC 50383-901-10.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the bottle to confirm if it's affected.
Contact Pharmacy
Talk to your pharmacy about whether this product is safe to use or if you need a replacement.
Questions people ask
Is this product dangerous?
The product has lower-than-stated hydrocortisone levels, which may make it less effective for ear infections, but it's not considered dangerous in normal use.
How do I know if I have the recalled product?
Check for the 10mL dropper bottle with lot number 364667 (expired 12/20/2019) from HI-TECH PHARMACAL CO., INC. in Amityville, NY.
What should I do if I have the recalled product?
Contact your pharmacy for guidance on whether to use it or get a replacement.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0839-2020 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0839-2020 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 5, 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.