Taro Pharmaceuticals Inc. recalls Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals
Taro Pharmaceuticals recalls Hydrocortisone 1% and Acetic Acid 2% Otic Solution due to impurity and assay issues. This RX-only product may pose risks from failed quality tests.
Lower-risk recall
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Contact the company & request your remedy
What happened, in plain English
Taro Pharmaceuticals is recalling Hydrocortisone 1% and Acetic Acid 2% Otic Solution because quality tests found impurities and lower-than-stated hydrocortisone levels. This could affect the product's safety and effectiveness for ear drops. Read more at govinfonow.com/recall/33012-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33012-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0089-2024
Cite this page
“Taro Pharmaceuticals Hydrocortisone Otic Solution Recall: Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33012-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurity-risk. Based on FDA recall #D-0089-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0089-2024%22&limit=1).
Why it’s dangerous
The product failed quality tests showing impurities and lower hydrocortisone levels than expected. This could mean the medication isn't as effective or safe as it should be for ear conditions.
Who’s affected
People with prescriptions for this ear drop medication are affected. Those using the product without a prescription are not impacted since it's RX-only.
How to tell if you have this one
Check for the 10ml dropper bottle labeled Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP. The product was manufactured by Taro Pharmaceuticals Inc. with lot numbers AC86809 or AC86812 and expires January 31, 2024.
- Brand
Taro Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product label includes Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP in a 10ml dropper bottle.
Questions people ask
Is this product safe to use?
The recall indicates quality test failures, but the product may still be safe for use. Taro Pharmaceuticals has not specified if it's unsafe.
What should I do if I have this product?
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
How can I confirm if my product is recalled?
Check the product label for the lot numbers AC86809 or AC86812 and expiration date of January 31, 2024.
Contact Taro Pharmaceuticals
We’ve drafted a message you can send Taro Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0089-2024 — Taro Pharmaceuticals Taro Pharmaceuticals Hello, I own a Taro Pharmaceuticals that is covered by recall D-0089-2024 from Taro Pharmaceuticals. 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-0089-2024 (November 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0089-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.