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Browse Drug Recalls

54 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 54 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 54 FDA drug recalls.

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DateProductReasonClassFirm
Apr 13, 2023 C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder ... Lack of assurance of sterility. 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 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 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
Jul 26, 2016 Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hat... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial,... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, ... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, cl... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, M... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, H... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostagla... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hatties... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hatt... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 3... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostagland... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder

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.