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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Jun 12, 2019 RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL;... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/25... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB,... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IV... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUM... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Inf... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARB... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; F... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBUL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OX... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 1... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... Defective Container; actuator may improperly function and affect dose delivery. Class III InvaGen Pharmaceuticals, Inc.
Jun 10, 2019 Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Preferred Pharmaceuticals, Inc
Jun 7, 2019 Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... Class III Akorn Inc
Jun 7, 2019 Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the... Class I PharMEDium Services, LLC
Jun 6, 2019 LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 6, 2019 LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihis... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye ... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free... cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... Class II P & L Developments, LLC
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 3, 2019 Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (... Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. Class II Glenmark Pharmaceuticals Inc., USA
May 31, 2019 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.
May 31, 2019 Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 16... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (4... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporati... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... Failed Dissolution Specifications: Out of specification result for dissolution. Class II Chiesi USA, Inc.

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.