Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 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 2,138 FDA drug recalls.

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DateProductReasonClassFirm
Sep 30, 2021 Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 1... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 9, 2021 Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only... Microbial contamination of non-sterile products: Firm's testing found lots to exceed specificatio... Class I Jacobus Pharmaceutical Company Inc.
Aug 27, 2021 Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG... Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total a... Class I DuPont Nutrition USA, Inc
Aug 24, 2021 Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laborator... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Dist... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, ... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Non-Sterility: firm's third party lab confirmed microbial contamination. Class I SterRx, LLC
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... Chemical Contamination: presence of benzene Class I Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... Chemical Contamination: presence of benzene Class I Johnson & Johnson Consumer, Inc.
Jul 7, 2021 Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... Presence of Foreign Substance- Potential of metal contamination. Class II Aurobindo Pharma USA Inc.
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... Class I Global Sanitizers LLC
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... Class I Global Sanitizers LLC
May 11, 2021 DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... Class I DIBAR NUTRICIONAL S DE RL DE CV
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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.
Mar 31, 2021 Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... Microbial Contamination of Non-Sterile Product Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 29, 2021 Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net C... Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans Class I Spartan Chemical Co Inc
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora... Class I CareFusion 213, LLC
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... Class I Sanit Technologies, LLC dba Durisan
Mar 10, 2021 aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, pa... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, pack... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... Class I Sanit Technologies, LLC dba Durisan
Feb 15, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials,... Chemical contamination; Unknown brown residue adhering to the inside of one vial. Class II Teva Pharmaceuticals USA
Dec 28, 2020 Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia... Class II Sunstar Americas, Inc.
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (4... Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast Class I NDAL Mfg Inc.
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA

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.