Browse Drug Recalls

2,151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,151 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 2,151 FDA drug recalls.

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DateProductReasonClassFirm
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
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Nov 17, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
Nov 17, 2020 REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (... Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit... Class I MPM Medical LLC
Nov 17, 2020 Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in... Cross contamination: the excipient was found to be contaminated with theophylline. Class II BASF Corporation
Nov 17, 2020 DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill... Cross Contamination with Other Products: trace amounts of octreotide found during testing Class III Fresenius Kabi USA, LLC
Oct 28, 2020 Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 m... Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer ... Class I Lohxa LLC
Oct 27, 2020 Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. Class I Sunstar Americas, Inc.
Sep 25, 2020 Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulde... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
Sep 25, 2020 Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Bould... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
Sep 25, 2020 Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO... Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. Class I Wishgarden Herbs, Incorporated
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
Aug 17, 2020 Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural... Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be cont... Class I Maison Terre, LLC
Aug 14, 2020 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-... Class I Grupo Asimex de Mexico SA de CV
Aug 6, 2020 Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kill... Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for e... Class I Incredible Products, SA de CV
Aug 4, 2020 Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250... CGMP Deviation: Potential contamination with undeclared methanol. Class II ROQUE PLAST, 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%), 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 22, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
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 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 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 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 6, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... Cross contamination with other products - OOS discovered during routine stability testing for hig... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 2, 2020 bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... Chemical Contamination: Product contains methanol. Class I AAA Cosmetica, SA de CV
Jul 1, 2020 Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), F... Microbial contamination of non-sterile products: positive microbial contamination in product. Class I Spartan Chemical Co Inc
Jun 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... Chemical Contamination: Presence of Undeclared Methanol Class I Transliquid Technologies, LLC
Jun 24, 2020 Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX O... Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia... Class I Medichem S.A.
Jun 23, 2020 All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%,... Chemical Contamination: Product contains undeclared methanol. Class I Itech 361 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.