Browse Drug Recalls

2,151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,151 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 2,151 FDA drug recalls.

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DateProductReasonClassFirm
May 2, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fe... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg ... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 P... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Mar 26, 2019 Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/... Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufact... Class III Medi-Physics Inc. dba GE Healthcare
Feb 20, 2019 Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Ag... Cross Contamination: Presence of IPA in finished product. Class II Vi-Jon, Inc.
Feb 13, 2019 Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gr... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 13, 2019 White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. Class I Todd Holiday dba Sunstone Organics
Feb 6, 2019 Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) b... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 f... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Feb 6, 2019 Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, E... Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... Class II Ecolab Inc
Nov 20, 2018 Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./... Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product Class II AVKARE Inc.
Nov 9, 2018 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... Cross contamination with other products: This sub-recall is being initiated in support of the rec... Class III AMERICAN HEALTH PACKAGING
Nov 7, 2018 Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... Cross contamination with other products: Product is being recalled due to the potential presence ... Class III RemedyRepack Inc.
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... Cross Contamination with Other Products Class III Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... Cross Contamination with Other Products Class III Sandoz Inc
Oct 9, 2018 Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 3, 2018 Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed... Microbial Contamination of Non-Sterile Products Class I Silver Star Brands
Oct 3, 2018 Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Silver Star Brands
Oct 3, 2018 Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Silver Star Brands
Oct 3, 2018 Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... Microbial Contamination of Non-Sterile Product Class I Silver Star Brands

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.