CLASS III Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalled
Taro Pharmaceuticals is recalling Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper, distributed nationwide in the US. The recall was initiated on 6 Nov 2023 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-0089-2024
- FDA event ID
- 93337
- Recalling firm
- Taro Pharmaceuticals, Brampton
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2023
- FDA classified
- 6 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 6 Nov 2023 | Recall initiated by company | |
| 6 Nov 2023 | Classified by FDA | +0 days |
| 15 Nov 2023 | Published in enforcement report | +9 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 result for Hydrocortisone related impurity 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% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalled?
Yes. Taro Pharmaceuticals recalled Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper on 6 Nov 2023. The recall is Class III and its status is Terminated. Recall number D-0089-2024.
Why was it recalled?
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.
Which lots are affected?
Lot# AC86809, AC86812, Exp Date: 01/31/2024
Where was it sold?
Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Taro Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desoximetasone Cream recalled by Taro PharmaceuticalsDesoximetasone | Taro Pharmaceuticals | Potency & Assay | PR |
| Drug | CLASS II | Desoximetasone Cream recalled by Taro PharmaceuticalsDesoximetasone | Taro Pharmaceuticals | Potency & Assay | PR |
| Drug | CLASS III | Topicort (desoximetasone) Topical Spray recalled by Taro PharmaceuticalsTopicort | Taro Pharmaceuticals | Potency & Assay | Nationwide |
Other Hydrocortisone recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment USP 1% Maximum Strength recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion recalledIntensive Healing Eczema | US Pharmaceuticals | Potency & Assay | Nationwide |