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Browse Drug Recalls

88 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 88 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 88 FDA drug recalls.

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DateProductReasonClassFirm
Jun 19, 2019 EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compound... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compo... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compoundi... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West Sta... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Co... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Com... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30M... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Com... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 W... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 Wes... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compound... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC

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.