Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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DateProductReasonClassFirm
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
Jun 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... Chemical Contamination: Presence of Undeclared Methanol Class I Transliquid Technologies, LLC
Jun 25, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen... Class II POLARIZED LLC
Jun 12, 2020 Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 12, 2020 Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%)... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 12, 2020 Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl ... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 10, 2020 Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured... Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tabl... Class II Alembic Pharmaceuticals Limited
Jun 10, 2020 Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... Class III American Health Packaging
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 3, 2020 Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim... Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. Class II Yusef Manufacturing Laboratories, LLC
May 28, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 28, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... Class II Glaxosmithkline Consumer Healthcare Holdings
May 19, 2020 LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings

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.