Hydrocortisone and Acetic Acid Otic Solution — Class II drug recall D-0839-2020
Terminated recall by Akorn Inc, reported 2020-02-19, distributed nationwide. Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
| Recall number | D-0839-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-02-11 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2022-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 16,078 bottles |
| Reason classes | potency, specification failure |
| NDC | 50383-0901-10 |
| Lot numbers | 364667 |
| Expiration dates | 2019-12-20 |
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Reason for recall
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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-0839-2020. 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.