Qualitest Recalls Hydrocortisone Acetic Acid Otic Solution Due to Impurities
Qualitest recalls specific lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL) due to impurity specification failures. Check your lot numbers.
Recall notice
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Contact the company
What happened, in plain English
Qualitest Pharmaceuticals is recalling Hydrocortisone and Acetic Acid Otic Solution, USP in 10 mL bottles because testing showed impurities exceeded specifications at the 18-month mark. The recall affects approximately 54,431 bottles distributed nationwide and in Puerto Rico. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/48650-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocortisone-and-acetic.
Source Summary by GovInfoNow · govinfonow.com/recall/48650-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocortisone-and-acetic · Updated October 13, 2026 · FDA enforcement record: FDA #D-1411-2012
Cite this page
“Qualitest Recalls Hydrocortisone Acetic Acid Otic Solution Due to Impurities.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48650-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocortisone-and-acetic. Based on FDA recall #D-1411-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1411-2012%22&limit=1).
Why it’s dangerous
The recalled solution contains impurities or degradation products that were found to be out of specification when tested at the 18-month room temperature time point. While the record does not specify the exact health consequences, using medication with unexpected impurities can pose safety risks.
Who’s affected
Consumers who purchased Hydrocortisone and Acetic Acid Otic Solution, USP (Rx only) from pharmacies across the United States and Puerto Rico before July 6, 2012. Individuals with these specific lot numbers are at risk of using a product that may not meet quality standards.
How to tell if you have this one
Check your bottle for NDC 0603-7039-39 and UPC 3 0603-7039-39 7. The product is a 10 mL Rx-only bottle manufactured by Qualitest Pharmaceuticals in Huntsville, AL. Affected lots include L072B11A (Exp 8/12), L102C11A and L103C11A (Exp 10/12), L046D11A, L082F11A, L089F11A (Exp 11/12), L148J11A, L149J11A, L150J11A (Exp 03/13), and L151J11A (Exp 04/13).
- Brand
Qualitest Pharmaceuticals- Product
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST…- Category
Drug
What to do — step by step
Check Your Lot Number
Compare the lot number on your bottle against the recalled lots listed in the record to see if your product is affected.
Contact Your Pharmacist
Since this is a prescription drug, consult your pharmacist or healthcare provider for guidance on what to do with the specific lot you have.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide 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 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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
Which expiration dates are affected by this recall?
Affected expiration dates include August 2012, October 2012, November 2012, March 2013, and April 2013, depending on the specific lot number.
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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-1411-2012 (July 6, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1411-2012 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.