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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 13, 2019 Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... Class II B. Braun Medical Inc
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II Baxter Healthcare Corporation
Jun 12, 2019 INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Av... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL... 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 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 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 Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, In... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IV... 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 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 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 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 SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% I... 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 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 OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLI... 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 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 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 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 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 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 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 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 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 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 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 CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CAR... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PE... 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 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 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 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 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 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 DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHA... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, In... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; R... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Option... 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 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 Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE;... Lack of Assurance of Sterility Class II Infusion Options, 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.