S-mic 25 recalls

The FDA has published 4 recalls involving S-mic 25 since 2019. The latest was reported on 13 Nov 2019. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 13 Nov 2019

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 4 100%Class III 0 0%

Why s-mic 25 is recalled

Sterility4100%

Companies

First Royal Care Co. LLC4100%

By year

20194100%

All s-mic 25 recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019Drug	CLASS II	S-mic 25/50/50mg/ML Cyano 1mg/ML Mdv Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019Drug	CLASS II	S-mic 25/50/50MG/ML Mdv Soln glass vial recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019Drug	CLASS II	S-mic 25/50/50mg/ML B12a1mg/ML Mdv Inj Soln recalled	First Royal Care Co. LLC	Sterility	Nationwide
13 Nov 2019Drug	CLASS II	S-mic 25/50/50 B12a 5mg/ML Mdv Soln recalled by First Royal Care Co. LLC	First Royal Care Co. LLC	Sterility	Nationwide

Should you stop taking S-mic 25?

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.