Lower risk Drug recall · FDA · Published August 7, 2024

Taro Pharmaceuticals Hydrocortisone Otic Solution Recall: Impurities Risk

Taro Pharmaceuticals recalls Hydrocortisone 1% & Acetic Acid 2% Otic Solution due to impurities and assay issues. This prescription ear drop may pose risks if used improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0633-2024Drug Taro Pharmaceuticals ›

Lower-risk recall

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Take action

Contact the company

Recalling firmTaro Pharmaceuticals U.S.A., Inc.3 Skyline Dr · Hawthorne, NY 10532-2174

✎ GovInfoNow plain-language explainer

Taro Pharmaceuticals is recalling prescription ear drops containing hydrocortisone and acetic acid because stability testing found impurities and lower-than-expected hydrocortisone levels. This could lead to unsafe concentrations if the product degrades over time. Read more at govinfonow.com/recall/32568-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32568-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0633-2024

Cite this page

“Taro Pharmaceuticals Hydrocortisone Otic Solution Recall: Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32568-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurities-risk. Based on FDA recall #D-0633-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0633-2024%22&limit=1).

The FDA announced on 2024-08-07 that Taro Pharmaceuticals U.S.A., Inc. voluntarily recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution due to failed impurity specifications. The Class III recall affects 96 vials distributed to one distributor.

How to tell if you have it

Brand: Taro Pharmaceuticals
Product: Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle
NDC: 51672-3007-01
Lot #: AD12890
Expiration: 09/30/2024
Quantity: 96 vials

The hazard

The recall was initiated because stability testing revealed out-of-specification results for related impurities and a slightly lower than established level of the Hydrocortisone Assay. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Taro Pharmaceuticals U.S.A., Inc. has 20 other recalls on record since 2012-11-21. Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30) and CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (2026-03-18).

How to tell if you have this one

Check for the 10 mL bottle labeled Hydrocortisone 1% & Acetic Acid 2% Otic Solution. The product was manufactured by Taro Pharmaceuticals, Inc. in Brampton, Ontario, Canada, with lot number AD12890 and expiration date 09/30/2024.

Brand
Taro Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the 10 mL bottle with the product name and lot number AD12890 on the label.

How this recall unfolded

Recall timeline

FDA published this recall 14 days after the firm started it.

Aug 7, 2024Firm started the recall
Aug 13, 2024FDA classified it Class III
Aug 21, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32568-taro-pharmaceuticals-hydrocortisone-otic-solution-recall-impurities-risk">Taro Pharmaceuticals Hydrocortisone Otic Solution Recall: Impurities Risk (GovInfoNow)</a>

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-0633-2024 (August 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0633-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.