Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Sep 10, 2018	Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- ND...	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 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	HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- ...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D So...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Te...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texa...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D So...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
Sep 10, 2018	Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Ho...	Lack of Assurance of Sterility	Class II	Pharm D Solutions, LLC
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 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	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	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	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 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	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 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	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	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	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 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	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 20000 IU Vial Lyophilized 1109 East Hallandale B...	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.
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 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.
Aug 2, 2018	Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandal...	Lack of assurance of sterility.	Class II	Pharmcore Inc.
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	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	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	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	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	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	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	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	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	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	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	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 (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	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
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	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

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.