Azithromycin recalls

The FDA has published 10 recalls involving Azithromycin since 2014. The latest was reported on 15 Jun 2022. Most were for manufacturing (cgmp) deviations. Wockhardt Usa has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls10since 2014
Last 12 months0reported
Class I00% of total
Ongoing0latest 15 Jun 2022

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 9 90%Class III 1 10%

Why azithromycin is recalled

Brands

By year

All azithromycin recalls, newest first

10 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAzithromycin for Injection USP Vial, 500 mg per vial recalledAzithromycinMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) recalledPD-Rx PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin Tablets, USP, 250 mg recalled by PD-Rx PharmaceuticalsPD-Rx PharmaceuticalsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin Tablets recalled by Wockhardt UsaWockhardt UsaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin Tablets recalled by Wockhardt UsaWockhardt UsaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin Tablets recalled by Wockhardt UsaWockhardt UsaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin tablets, USP 600mg recalled by American Health PackagingAmerican Health PackagingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin tablets, USP 250mg recalled by American Health PackagingAmerican Health PackagingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIAzithromycin tablets, USP 500mg recalled by American Health PackagingAmerican Health PackagingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIIZithromax (azithromycin for injection), 500 mg/vial, Sterile recalledZithromaxPfizerPotency & AssayNationwide

Should you stop taking Azithromycin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.