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Browse Drug Recalls

6,252 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,252 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 6,252 FDA drug recalls.

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DateProductReasonClassFirm
Apr 20, 2016 Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Ca... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syr... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pha... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chlor... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plung... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 6... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Onl... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compou... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compou... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pha... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Casse... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compound... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Onl... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey),... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx On... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx On... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Bra... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Com... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoj... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/m... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syri... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Mono... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx O... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV U... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHAR... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.

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.