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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.