DermOtic Oil — Class II drug recall D-0637-2021
Terminated recall by Hill Dermaceuticals, Inc., reported 2021-06-30, distributed nationwide. Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
| Recall number | D-0637-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill Dermaceuticals, Inc., Sanford, FL, United States |
| Recall initiated | 2021-05-21 |
| Classified | 2021-06-23 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| NDC | 68791-0103, 68791-0103-20 |
| Lot numbers | 02/22, 03/22, 04/22, 05/21, 06/22, 07/21, 09/21, 09/22, 12/21, 19K036D, 19L039E, 20A001E, 20A003D, 20A003E, 20C013G, 20E025F, 20E025G, 20E025H, 20H041D, 20H041F, 20J043E, 20K050F, 20L055E, 21C015E, 21C018E |
Product
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Reason for recall
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
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-0637-2021. 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.