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Browse Drug Recalls

50 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 50 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 50 FDA drug recalls.

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DateProductReasonClassFirm
Sep 18, 2019 Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... Lack of sterility assurance. Class II Avella of Deer Valley, Inc. Store 38
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
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
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

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.