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Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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DateProductReasonClassFirm
Aug 2, 2018 Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandal... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale B... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Halla... Lack of assurance of sterility. Class II Pharmcore Inc.
Jul 25, 2018 Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Labor... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 ... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier'... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laborat... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 m... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) I... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jul 25, 2018 Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laborator... Lack of Assurance of Sterility: Practices at firm may call into question the sterility of product... Class II Ranier's Compounding Laboratory
Jun 25, 2018 Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Wate... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 14, 2018 Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syr... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL ba... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharm... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chlor... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
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 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 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 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 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 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 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
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 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 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 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 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 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 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 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 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

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.