Browse Drug Recalls

514 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 514 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 514 FDA drug recalls in AZ.

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Date	Product	Reason	Class	Firm
Aug 12, 2019	S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. R...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain C...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compou...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25M...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compound...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Moun...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain C...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Com...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mo...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Re...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only,...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Com...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compoun...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mounta...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV,...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compoun...	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019	S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	Class II	First Royal Care Co. LLC, dba Red Mountain Comp...
May 3, 2019	Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Apr 8, 2019	TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alpros...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML)...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYD...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadi...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Mar 12, 2019	15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceutic...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Feb 8, 2019	MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use ...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use b...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Feb 8, 2019	MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Com...	Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (...	Class II	Avella of Deer Valley, Inc. Store 38
Oct 31, 2018	BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n...	Lack of Assurance of Sterility	Class II	Avella of Deer Valley, Inc. Store 38
Oct 19, 2018	Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Oct 19, 2018	Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Oct 19, 2018	Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Oct 19, 2018	Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Ave...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Oct 19, 2018	Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/...	Lack of assurance of sterility	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL sing...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose ...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride ...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose ...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chlor...	Lack of Assurance of Sterility: Potential leakage of bags.	Class II	Avella of Deer Valley, Inc. Store 38

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.