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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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DateProductReasonClassFirm
Sep 12, 2019 NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropic... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Us... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 6, 2019 Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... Lack of Assurance of Sterility Class II Pfizer Inc.
Aug 30, 2019 Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single u... Lack of assurance of sterility. Class II Pacifico National, Inc. dba AmEx Pharmacy
Aug 30, 2019 Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single ... Lack of assurance of sterility. Class II Pacifico National, Inc. dba AmEx Pharmacy
Aug 16, 2019 Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (conce... Lack of Assurance of Sterility. Class II SCA Pharmaceuticals, LLC
Aug 12, 2019 S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mo... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain C... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compoundin... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compoundin... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Co... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red ... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. ... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mo... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compoun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mo... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. R... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c)... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountai... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compoundi... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Onl... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glas... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain C... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass via... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Com... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Re... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compound... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml,... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass v... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S071720... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PRO... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irriga... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compo... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Moun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...

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.