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Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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
May 31, 2019 Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 m... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corpora... 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 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 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 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 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 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 22, 2019 Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... Failed Impurities/Degradation Specifications. Class III Fresenius Kabi USA, LLC
May 6, 2019 Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceutica... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
May 6, 2019 Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Ger... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
Apr 30, 2019 Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Onl... Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product Class I Par Pharmaceutical, Inc.
Apr 29, 2019 Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ... Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax... Class III Pfizer Inc.
Mar 29, 2019 Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ... Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration... Class III X-Gen Pharmaceuticals Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 15, 2019 Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 m... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer 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.