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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
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 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 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 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
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 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 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 26, 2022 QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusio... 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 TRI-MIX 30/2/20 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 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
Aug 26, 2022 MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion L... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, ... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infu... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 B... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, ... 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 TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Car... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC,... Lack of Assurance of Sterility Class II Carolina Infusion
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 TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 26, 2022 TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Car... Lack of Assurance of Sterility Class II Carolina Infusion
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 22, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Aug 2, 2022 Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... Lack of Assurance of Sterility: Complaints received of defective container closure. Class II CIPLA
Jul 27, 2022 Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Jul 25, 2022 fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 25, 2022 FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 14, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Jun 30, 2022 Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Fi... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, pac... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged i... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC

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.