Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
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-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 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-AMITRIPTYLINE 10MG/ML MDV INJ 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-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Moun... 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-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-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compoundi... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml droppe... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, 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-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-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain C... 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-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mounta... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass v... 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-ESTRADIOL VALERATE 20MG/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-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-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML 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-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, 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-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-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV,... 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-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-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-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-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mo... 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-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-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-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-GLYCERIN 72% INJECTION SOLN, 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-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...
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 I... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx onl... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy

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.