Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP — Class III drug recall D-0089-2024
Terminated recall by Taro Pharmaceuticals Inc., reported 2023-11-15, distributed nationwide. Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity a
| Recall number | D-0089-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals Inc., Brampton, Canada |
| Recall initiated | 2023-11-06 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Terminated | 2024-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 11,196 bottles |
| Reason classes | potency, specification failure |
| NDC | 51672-3007, 51672-3007-01 |
| Lot numbers | AC86809, AC86812 |
| Expiration dates | 2024-01-31 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0089-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.