CLASS III Drug recall · Reported 21 Aug 2024 · FDA Enforcement Report
Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled
Taro Pharmaceuticals U is recalling Hydrocortisone 1% & Acetic Acid 2% Otic Solution. The recall was initiated on 7 Aug 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0633-2024
- FDA event ID
- 95125
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 7 Aug 2024
- FDA classified
- 13 Aug 2024
- Reported
- 21 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Aug 2024 | Recall initiated by company | |
| 13 Aug 2024 | Classified by FDA | +6 days |
| 21 Aug 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Where it was distributed
Product was distributed to one distributor
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # AD12890, Exp 09/30/2024
Where was it sold?
Product was distributed to one distributor
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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