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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 13, 2021 MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compound... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compound... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 1... 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-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-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-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-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-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle... 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-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-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...

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.