Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Ongoing Initiated Dec 6, 2016 (10 years ago)

INOVA (benzoyl peroxide)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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

Affected NDC 68712-0013-01

Compare with the code on your package — it is the most precise check available.

Recalling firm
Cipher Pharmaceuticals US LLC
NDC code
68712-013-01
Origin
SC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0237-2017 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.

Other wrong potency / content recalls from 2016

All wrong potency / content recalls
Class III · Low risk

Aripiprazole Tablets

Superpotent Drug; out of specification results for assay (manufacturer)

Terminated Wrong potency / content The Harvard Drug Group NDC 0904-6509-04 D-0692-2017