Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III Fresenius Medical Care Holdings, Inc.
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... Failed Impurities/Degradation Specifications Class III KVK-Tech, Inc.
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 26, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 21, 2021 Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Heritage Pharmaceuticals Inc
Apr 20, 2021 Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... Class III Genentech Inc
Apr 20, 2021 BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... Defective Delivery System: An increase in complaints identified endcap being loose or falling off... Class I CareFusion 213, LLC
Apr 19, 2021 Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato... Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... Class III SigmaPharm Laboratories LLC
Apr 19, 2021 Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator... Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... Class III SigmaPharm Laboratories LLC
Apr 16, 2021 Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, ... Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... Class II Noven Pharmaceuticals Inc
Apr 16, 2021 Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box... Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... Class II Noven Pharmaceuticals Inc
Apr 15, 2021 Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medi... cGMP deviations Class II Grace Healthcare Medical, Inc
Apr 14, 2021 Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a... Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. Class II Fresenius Medical Care, North America
Apr 13, 2021 Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein S... Subpotent Drug Class III Nomax Inc
Apr 12, 2021 Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... Class II Preferred Pharmaceuticals, Inc.
Apr 12, 2021 Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, ... Defective container; syringe content migrating past the seal of the plunger may cause a lack of a... Class II Edge Pharma, LLC
Apr 9, 2021 Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pha... Failed Impurities/Degradation Specifications: Class II Teligent Pharma, Inc.
Apr 8, 2021 Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Ang... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Apr 8, 2021 Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Apr 6, 2021 PremierZen Black 5000, packaged in cardboard blisters containing one capsul... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class II Hyobin LLC
Apr 6, 2021 Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one ... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class II Hyobin LLC
Apr 6, 2021 PremierZen Extreme 3000, packaged in cardboard blisters containing one caps... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class II Hyobin LLC
Apr 1, 2021 Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 31, 2021 PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC ... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II QMart
Mar 31, 2021 Imperial Platinum 2000, 1 capsule, UPC 718122040702 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II QMart
Mar 31, 2021 Burro en Primavera, 2 capsules, UPC 638632431055 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II QMart
Mar 31, 2021 Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... Class II Apotex Corp.

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.