Browse Drug Recalls

1,723 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,723 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 1,723 FDA drug recalls — Class I.

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DateProductReasonClassFirm
Dec 21, 2021 SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per... Microbial Contamination of Non-Sterile Product Class I Lohxa, LLC
Dec 15, 2021 Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria Class I Taro Pharmaceuticals U.S.A., Inc.
Dec 6, 2021 kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Valisa MFG LLC
Dec 3, 2021 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... Class I Gilead Sciences, Inc.
Nov 30, 2021 Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Aroma Release Technologies Inc
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug Class I Teligent Pharma, Inc.
Nov 23, 2021 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deo... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily,... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topica... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, To... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, ... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 19, 2021 AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I American Screening LLC
Nov 17, 2021 Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... Chemical contamination: Presence of benzene Class I Blistex Inc
Nov 17, 2021 Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... Temperature Abuse; temperature excursion during shipping Class I Sandoz Inc
Oct 26, 2021 artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... Chemical Contamination: presence of benzene, acetaldehyde, and acetal. Class I VIRGIN SCENT INC
Oct 19, 2021 Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... Presence of Particulate Matter: Identified as Glass Particles Class I MERCK SHARP & DOHME CORP
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... Superpotent Drug Class I Teligent Pharma, Inc.
Oct 12, 2021 Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Oct 1, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dis... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals Inc.
Oct 1, 2021 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... Chemical Contamination: presence of benzene Class I Bayer Healthcare Pharmaceuticals 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 30, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... Chemical contamination; presence of benzene Class I Beiersdorf Inc
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 24, 2021 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per ... SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. The... Class I Eli Lilly & Company
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.
Sep 3, 2021 AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... Class I ICU Medical 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 Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit... Product Mix-up: Incorrect diluent component included in the kit. Class I Azurity Pharmaceuticals, Inc.
Aug 18, 2021 X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 1368... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I Phe Inc
Aug 11, 2021 Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x ... Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine Class I Ebay Seller - John Nguyen
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
Aug 3, 2021 Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... Superpotent Drug Class I Teligent Pharma, Inc.
Aug 2, 2021 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Je Dois Lavoir LLC
Jul 16, 2021 ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil Class I Alpha-Tek 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 14, 2021 Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. Class I Qikmoov LLC
Jul 2, 2021 Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... Temperature abuse: the firm received customer complaints of unusual grittiness in the product. Class I KVK-Tech, Inc.
Jun 22, 2021 Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I Ardil Comercial S.R.L.
Jun 21, 2021 Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitiz... Hand sanitizer packaged in bottles that resemble beverage containers. Class I Prairie Wolf Spirits

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.