Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
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 BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVAC... 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 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 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 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 ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-T... 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 Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG /... 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 VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VI... 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 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 AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTI... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCO... 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 ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL... 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 ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the ... 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 TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRA... 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 PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 592... 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 PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS... 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 METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; ME... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the A... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELC... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; E... 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 IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRIN... 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 HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; H... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G,... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML N... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13... 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 TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
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 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 Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytara... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PRESERVATIVE FREE 0.9% NACL 5 ML SYR, Rx Only, Infusion Options, Inc. 5924 13... 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.
May 30, 2019 Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... Lack of sterility assurance. Class II Surgery Pharmacy Services 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.