Daptomycin recalls

The FDA has published 5 recalls involving Daptomycin since 2018. The latest was reported on 8 Mar 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare 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 recalls5since 2018

Last 12 months0reported

Class I240% of total

Ongoing0latest 8 Mar 2023

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 2 40%Class II 3 60%Class III 0 0%

Why daptomycin is recalled

Companies

By year

2023360%
2020120%
2018120%

All daptomycin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Drug	CLASS II	Daptomycin for Injection 350 mg/vial recalled by Accord HealthcareDaptomycin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Daptomycin for Injection 500 mg per vial, Single-dose vial recalledDaptomycin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
25 Jan 2023Drug	CLASS I	Daptomycin for Injection 350 mg/vial-dose vial recalled	Accord Healthcare	Packaging Defects	Nationwide
12 Aug 2020Drug	CLASS I	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial recalledDaptomycin	Mylan Institutional	Particulate Matter	Nationwide
8 Aug 2018Drug	CLASS II	Daptomycin for Injection, 500 mg per vial, packaged as-dose vial recalled	PFIZER	Sterility	Nationwide

Should you stop taking Daptomycin?

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.