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Browse Drug Recalls

18 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 18 FDA drug recalls.

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DateProductReasonClassFirm
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 pipette of the dropper. Class II Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oi... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical O... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
Jan 31, 2014 SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), ... Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
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 be subpotent during t... Class III Hill Dermaceuticals, Inc.
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o... Subpotent; 12 month stability timepoint Class III Hill Dermaceuticals, Inc.
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on... Subpotent; 22 month stability timepoint Class III Hill Dermaceuticals, Inc.
Aug 15, 2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For ... Subpotent; fluocinolone acetonide. Class III Galderma Laboratories, L.P.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28m... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.
May 8, 2012 Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl... Subpotent; fluocinolone acetonide Class III Hill Dermaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.