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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Oct 11, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... Class II Fresenius Medical Care Holdings, Inc.
Oct 11, 2022 NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ... Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg Class III LNK International, Inc.
Oct 7, 2022 MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx o... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vita... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Class I Viatris Inc
Oct 7, 2022 CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care C... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTI... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vi... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 m... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital C... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compo... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder,... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vita... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit do... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL via... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTI... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials,... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vita... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S.... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials,... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUT... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Comp... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Ca... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL sy... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 7, 2022 MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital ... Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Oct 6, 2022 Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Golden State Medical Supply Inc.
Oct 6, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Pat... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Golden State Medical Supply Inc.
Oct 6, 2022 SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL)... CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. A... Class II Southwest Iowa Renewable Energy LLC
Oct 5, 2022 Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Aurobindo Pharma USA Inc.
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Oct 4, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D... Defective Container: Complaints received of vial breakage and glass flying when pressurized while... Class I Exela Pharma Sciences LLC
Sep 30, 2022 Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured ... Out of specification for related substances (impurities). Class II Ingenus Pharmaceuticals Llc
Sep 30, 2022 Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Class II VistaPharm, Inc.
Sep 30, 2022 Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled... Subpotent Drug: Out of specification for assay Class II AuroMedics Pharma LLC
Sep 29, 2022 Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL... Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets Class I Golden State Medical Supply Inc.
Sep 29, 2022 Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose... Lack of Assurance of Sterility: environmental monitoring failure. Class II CIPLA
Sep 27, 2022 Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. Class II Pfizer Inc.
Sep 26, 2022 Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate fl... Class II AuroMedics Pharma LLC
Sep 26, 2022 Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... Presence of Particulate Matter: Piece of metal found in a vial Class III AuroMedics Pharma LLC
Sep 21, 2022 Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.

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.