Browse Drug Recalls

378 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 378 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 378 FDA drug recalls in N/A.

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DateProductReasonClassFirm
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
Oct 15, 2019 Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpo... 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-Ithurts, 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-Immunexx, 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-Arthros, 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-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... 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-Infla, 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-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporate... 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-Prolo, 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 3, 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-ANS/CNS, 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-Lymph 1, 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-Collagen, 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-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio I... 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-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... 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-Articula, 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-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... 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-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... Class II 8046255 Canada Inc. DBA Viatrexx
Oct 7, 2019 Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan I... Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity resu... Class II Mylan Laboratories Limited (Sterile Products Di...
Sep 24, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Jul 16, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Apr 1, 2019 ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 4... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ing... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl o... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl ... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%),... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019 DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... Class III NingBo Huize Commodity Co.,Ltd.

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.