Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Sep 10, 2018 HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50 Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solut... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 696... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Aug 21, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Be... 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.
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 Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale ... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale B... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
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 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 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 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 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 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 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
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 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 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 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 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 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 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 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
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 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 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 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 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 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

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.