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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Dec 27, 2022 VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Class III Jubilant Cadista Pharmaceuticals, Inc.
Dec 27, 2022 KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion ... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharma... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infu... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infus... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharma... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27G... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home I... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx On... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, R... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sen... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara ... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx On... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home I... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used w... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c)... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infu... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Se... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sent... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LI... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curli... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pu... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, u... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 ... Lack of sterility assurance Class II Sentara Infusion Services
Dec 23, 2022 Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hyd... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Ca... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Bur... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 22, 2022 GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Inn... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTA... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharma... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations

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.