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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
Dec 22, 2022 LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 29... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Nov 25, 2022 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... Lack of sterility assurance: Bags have the potential to leak. Class II B. Braun Medical, Inc.
Nov 22, 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.
Nov 9, 2022 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ... Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which ... Class II ICU Medical Inc
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 / 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 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 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 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/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 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 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 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 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 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 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
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 15, 2022 Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 ... Lack of Assurance of Sterility Class II CIPLA
Aug 31, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 31, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 26, 2022 TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Caro... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infu... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, R... Lack of Assurance of Sterility Class II Carolina Infusion

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.