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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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DateProductReasonClassFirm
Jun 12, 2018 NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropiva... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodiu... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacai... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 1... 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 30 mg, 0.9% Sodium Chloride, USP QS 30 m... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (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 MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP)... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chlorid... 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 0.9% Sodium ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL)... 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) 100 mg, Sodium Chloride, USP QS 100 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% De... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 150 mg (Morphine Sulfate, USP 150mg in 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 HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dex... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextros... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 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 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 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 ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Sin... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP Q... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Apr 24, 2018 Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phe... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, steri... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile inj... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vital... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Jan 26, 2018 Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Oct 10, 2017 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Phar... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chlo... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Onl... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Com... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Bann... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner ... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, 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.