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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 3,821–3,840 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10

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

Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61

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

Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61

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

Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

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

Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06

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

Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27

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

Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC

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

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01

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

Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31

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

Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13

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

Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87

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

Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56

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

HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

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

Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30

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

Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05

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

Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16

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

Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55

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

ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55

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

Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25

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

Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

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.