Browse Drug Recalls

2,029 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,029 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 2,029 FDA drug recalls.

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DateProductReasonClassFirm
Sep 17, 2020 NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... Labeling: Product Contains Undeclared API; Incorrect formulation Class III Grato Holdings, Inc.
Sep 11, 2020 Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactu... Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... Class II Genesis Partnership Company SA
Sep 11, 2020 Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manuf... Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... Class II Genesis Partnership Company SA
Sep 9, 2020 M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... Class I MEDEK LLC
Sep 9, 2020 Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... Class III P & L Developments, LLC
Sep 3, 2020 Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99... Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an... Class I CORGIOMED LLC
Sep 1, 2020 Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... Class I The Protein Shoppe
Aug 17, 2020 Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 17, 2020 Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ... Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai... Class I Mylan Institutional LLC
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: ... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Boli... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Al... Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the la... Class I Volu-Sol, Inc.
Aug 14, 2020 Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packag... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 14, 2020 SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG2... Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una... Class I SG24 LLC
Aug 10, 2020 Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannet... Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contai... Class II Lannett Company, Inc.
Aug 7, 2020 Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in ... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 7, 2020 Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-... Labeling Not Elsewhere Classified: Product labeled to contain methanol Class II Open Book Extracts
Aug 3, 2020 Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol ... Labeling Not Elsewhere Classified: Product labeled to contain methanol. Class II Leiper's Fork Distillery
Jul 31, 2020 Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... Class III The Mentholatum Company
Jul 30, 2020 Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 27, 2020 HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below ... Class I Broncolin, S.A. de C.V.
Jul 23, 2020 BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packa... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 23, 2020 LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, ... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 23, 2020 BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 ... Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol con... Class I Real Clean Distribuciones SA de CV
Jul 23, 2020 scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcoh... CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... Class II Real Clean Distribuciones SA de CV
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L)... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L)... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) d... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 20, 2020 OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (... Chemical Contamination: Products contain methanol and were below the label claim for ethanol content Class I Liq-E S.A. De C.V.
Jul 16, 2020 HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biol... Labeling: Error on Declared Strength Class II Grato Holdings, Inc.
Jul 14, 2020 Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: A... Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not ... Class II Teva Pharmaceuticals USA
Jul 13, 2020 Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... Class III Fresenius Kabi USA, LLC
Jul 11, 2020 blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 9, 2020 Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottl... CGMP Deviations: Products manufactured at the same site were FDA testing found below the label cl... Class II Maquiladora Miniara Sa De Cv
Jul 7, 2020 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jul 7, 2020 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jul 2, 2020 Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446... Labeling: Label Error on Declared Strength Class II Edge Pharma, LLC

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.