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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Aug 9, 2023 YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, pa... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Feb 24, 2023 Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... CGMP DEVIATIONS Class II Ecometics, Inc.
Feb 24, 2023 Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... CGMP DEVIATIONS Class II Ecometics, 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.