Azithromycin recalls

The FDA has published 8 recalls involving Azithromycin since 2015. The latest was reported on 15 Jun 2022. Most were for manufacturing (cgmp) deviations. American Health Packaging 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 recalls8since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Jun 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why azithromycin is recalled

Manufacturing (CGMP) Deviations8100%

Companies

American Health Packaging338%
Wockhardt Usa338%
PD-Rx Pharmaceuticals113%
Mckesson Medical-Surgical Inc. Corporate Office113%

By year

2022113%
2016113%
2015675%

All azithromycin recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
15 Jun 2022Drug	CLASS II	Azithromycin for Injection USP Vial, 500 mg per vial recalledAzithromycin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
13 Jan 2016Drug	CLASS II	Azithromycin Tablets, USP, 250 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
29 Jul 2015Drug	CLASS II	Azithromycin Tablets recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide
29 Jul 2015Drug	CLASS II	Azithromycin Tablets recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide
29 Jul 2015Drug	CLASS II	Azithromycin Tablets recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015Drug	CLASS II	Azithromycin tablets, USP 600mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015Drug	CLASS II	Azithromycin tablets, USP 250mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015Drug	CLASS II	Azithromycin tablets, USP 500mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide

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.