INOVA — Class III drug recall D-0237-2017
Ongoing recall by Cipher Pharmaceuticals US LLC, reported 2017-01-04, distributed in AZ, CO, OH. Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within
| Recall number | D-0237-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipher Pharmaceuticals US LLC, Daniel Island, SC, United States |
| Recall initiated | 2016-12-06 |
| Classified | 2016-12-28 |
| Reported by FDA | 2017-01-04 |
| Distributed | AZ, CO, OH |
| Quantity | 216 boxes |
| Reason classes | labeling, potency, specification failure |
| NDC | 68712-0013-01 |
| Lot numbers | 01316L02, 6871201301 |
Product
INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
Reason for recall
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
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-0237-2017. 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.