Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc.,
Akorn recalls Hydrocortisone and Acetic Acid Otic Solution due to potential subpotent drug levels detected in stability testing. This affects certain Rx-only bottles sold by Hi-Tech Pharmacal Co, Inc. in Amityville, NY.
Lower-risk recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Hydroc: 10 mL otic solution bottles that may have lower-than-stated drug levels. This could mean the treatment is less effective than intended, but it does not pose an immediate safety risk to users. Read more at govinfonow.com/recall/39110-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39110-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1011-2019
Cite this page
“Akorn Hydrocortisone Otic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39110-akorn-hydrocortisone-otic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-1011-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1011-2019%22&limit=1).
Why it’s dangerous
The product was found to have lower-than-stated hydrocortisone levels during routine stability testing at 12 months. This means the medication might not work as intended for treating ear inflammation or infections.
Who’s affected
People with prescriptions for this ear drop solution who purchased it from Hi-Tech Pharmacal Co, Inc. in Amityville, NY. Those with chronic ear conditions may be most affected due to potential reduced effectiveness.
How to tell if you have this one
Check for the 10 mL dropper bottle labeled 'Hydrocortisone and Acetic Acid Otic Solution, USP, Rx only'. The NDC code 50383-901-10 and lot number 357647 (expiring April 2019) are specific identifiers.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC code 50383-901-10 and lot number 357647 on the bottle label.
Questions people ask
Is this product safe to use?
The recall is due to potential lower-than-stated drug levels, not an immediate safety risk. The product may still be effective for some users but could be less effective than intended.
How can I tell if I have the recalled product?
Look for the NDC code 50383-901-10 and lot number 357647 on the bottle label. The product was sold by Hi-Tech Pharmacal Co, Inc. in Amityville, NY.
What should I do if I have this product?
The recall does not require immediate action. Check the product details and contact your healthcare provider for advice on whether to continue using it.
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-1011-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1011-2019 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-1011-2019 (March 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1011-2019 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.