Akorn Hydrocortisone and Acetic Acid Otic Solution Recall

Why it was recalled

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

Product description

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10

Lot numbers, UPCs & expiration codes

Lot: 357647, EXP 04/2019

Where it was sold

Nationwide USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1011-2019
Classification: Class II
Status: Terminated
Recall initiated: Mar 12, 2019
FDA report date: Mar 27, 2019
Quantity: 15,322 10 ml bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Akorn Inc

Original FDA data

Every field from FDA enforcement report D-1011-2019, exactly as published.

Show all FDA fields

City: Lake Forest
State: IL
Status: Terminated
Country: United States
Event ID: 82375
Address: 1925 W Field Ct Ste 300
Code information: Lot: 357647, EXP 04/2019
Postal code: 60045-4862
Report date: Mar 27, 2019
Product type: Drugs
Recall number: D-1011-2019
Classification: Class II
Recalling firm: Akorn Inc
Product quantity: 15,322 10 ml bottles
Termination date: Aug 1, 2022
Reason for recall: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
Distribution pattern: Nationwide USA and Puerto Rico
Recall initiation date: Mar 12, 2019
Initial firm notification: Letter
Center classification date: Mar 20, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1011-2019, published Mar 27, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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