Hill Dermaceuticals, Inc.

Complete recall history across all FDA and CPSC categories — 17 total recalls

Hill Dermaceuticals, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (17)

FDA drug safety enforcement actions by Hill Dermaceuticals, Inc.

Date Product Reason Class
May 21, 2021 DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx ... Presence of Foreign Substance: Potential for broken glass within the glass pi... Class II
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical O... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Sep 8, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
Sep 8, 2013 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to b... Class III
May 7, 2013 Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 11... Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to b... Class III
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o... Subpotent; 12 month stability timepoint Class III
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on... Subpotent; 22 month stability timepoint Class III
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28m... Subpotent; fluocinolone acetonide Class III
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl... Subpotent; fluocinolone acetonide Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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