Dimethicone recalls

The FDA has published 3 recalls involving Dimethicone since 2014. The latest was reported on 28 Dec 2016. 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 recalls3since 2014

Last 12 months0reported

Class I133% of total

Ongoing0latest 28 Dec 2016

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 33%Class II 2 67%Class III 0 0%

Why dimethicone is recalled

Sterility267%
Manufacturing (CGMP) Deviations133%

Companies

Sage Products3100%

By year

2016267%
2014133%

All dimethicone recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
28 Dec 2016Drug	CLASS II	Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier	Sage Products	Manufacturing (CGMP) Deviations	Nationwide
28 Dec 2016Drug	CLASS I	Comfort Shield (dimethicone) Barrier Cream Cloths recalledComfort Shield Barrier	Sage Products	Sterility	Nationwide
10 Sep 2014Drug	CLASS II	Comfort Shield Barrier Cream Cloths with dimethicone a) recalledComfort Shield Barrier	Sage Products	Sterility	Nationwide

Should you stop taking Dimethicone?

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.