Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
Dec 22, 2022 PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1M... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovati... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFI... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2M... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclospori... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx On... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovat... 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 KETAMINE 50MG/ML (10ML 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 Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy I... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx O... 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 Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations,... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIO... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovatio... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St.,... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENT... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 21, 2022 Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... Class III Apotex Corp.
Dec 20, 2022 Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... Failed Impurities/Degradations Specifications Class II Amerisource Health Services LLC
Dec 20, 2022 Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,... Failed Impurities/Degradation specifications Class II RemedyRepack Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 16, 2022 Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... Class II Hikma Pharmaceuticals USA Inc.
Dec 16, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Dec 15, 2022 Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918... cGMP Deviations Class II Frenda Corporation
Dec 15, 2022 Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr... cGMP Deviations Class II Frenda Corporation
Dec 12, 2022 Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 12, 2022 Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin... Class II Lupin Pharmaceuticals Inc.
Dec 12, 2022 ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ... cGMP Deviations Class II Atlantic Management Resources Ltd.
Dec 9, 2022 Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... Class II NCH Life Sciences LLC
Dec 8, 2022 Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/... Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... Class II McGuff Compounding Pharmacy Services, 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.