Browse Drug Recalls

415 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 415 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 415 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Sep 11, 2020 Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guate... CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... Class II Genesis Partnership Company SA
Sep 11, 2020 Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon ... CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... Class II Genesis Partnership Company SA
Aug 25, 2020 Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 F... Lack of CGMPs: Class II Asiaticon, SA de CV
Aug 25, 2020 V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC... Lack of CGMPs: Class II Asiaticon, SA de CV
Aug 18, 2020 Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg... GMP Deviations: Potential to contain 1-propanol. Class II Nanomateriales Sa De Cv
Aug 18, 2020 Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33... GMP Deviations: Potential to contain 1-propanol. Class II Nanomateriales Sa De Cv
Aug 18, 2020 Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... cGMP Deviations Class II GRUPO YACANA MEXICO SAS DE CV
Aug 18, 2020 Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... cGMP Deviations Class II GRUPO YACANA MEXICO SAS DE CV
Aug 14, 2020 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... CGMP Deviations: All other lots are being recalled because they were manufactured under the same ... Class II Grupo Asimex de Mexico SA de CV
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 Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufacture... Failed Tablet/Capsule Specification; complaint of bulging tablet Class II Hetero Labs Limited (Unit V)
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 31, 2020 Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged ... cGMP deviations Class II Laboratorios Jaloma S.A. de C.V.
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 27, 2020 HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... CGMP Deviations: products were recalled because they were manufactured in the same facility as th... Class II Broncolin, S.A. de C.V.
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 scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL... CGMP Deviations: Other products were recalled because they were manufactured in the same facility... Class II Real Clean Distribuciones SA de CV
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 14, 2020 Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Dis... cGMP Deviations Class II Soluciones Cosmeticas, SA de CV
Jul 2, 2020 bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... CGMP Deviations Class II AAA Cosmetica, SA de CV
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
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 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 5, 2020 Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Marksans Pharma Limited
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.
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage Inc
Jan 28, 2020 Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufact... Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tabl... Class II Graviti Pharmaceuticals Private Limited
Jan 16, 2020 Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 ba... Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturi... Class II Shandex Personal Care Manufacturing Inc.
Dec 13, 2019 RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Granules India Limited
Oct 15, 2019 Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019 Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019 Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019 Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019 Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 15, 2019 Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio ... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx

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.