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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
Jun 21, 2019 ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural 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.