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Browse Drug Recalls

140 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 140 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 140 FDA drug recalls.

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DateProductReasonClassFirm
Aug 12, 2019 S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mo... 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-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-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 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-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml ... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b)... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, 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-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-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-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-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-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml gla... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Moun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glas... 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-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-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mount... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper ... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Com... 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-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vi... 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-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-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mounta... 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-SOD CITRATE 4% INJ SOLN MDV, 10 ML 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-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Re... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vi... 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-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass via... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) ... 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-EDETATE DISODIUM 15% INJ, packaged in 50ml 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-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-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-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Onl... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml 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-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...
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-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-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-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX 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.