Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2022 | GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Inn... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OL... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYC... | 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 | 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 | GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 293... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, ... | 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 | 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 | 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 | 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 22, 2022 | TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 293... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylc... | 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 | 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 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTA... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | Ethyl Alcohol 95% (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 | 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 | Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| 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 | 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.