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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 3,781–3,800 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01 (current)

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label, Rx only, MFG: Baxter, NDC# 0338-0322-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.