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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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/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 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 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 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 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 12, 2021 Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (... Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the... Class II ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Non-Sterility: firm's third party lab confirmed microbial contamination. Class I SterRx, LLC
Aug 2, 2021 Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stabil... Class II Akorn, Inc.
Jul 30, 2021 FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R... Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen... Class II Custopharm, Inc.
Jul 30, 2021 Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For ... Lack of sterility assurance Class II BayCare Integrated Service Center, LLC /dba Bay...
Jul 29, 2021 Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Tev... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA

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.