Sildenafil recalls

The FDA has published 6 recalls involving Sildenafil since 2014. The latest was reported on 19 Aug 2026. Most were for hidden drug ingredients. Shoolin Pharma Chem 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 recalls6since 2014

Last 12 months2reported

Class I00% of total

Ongoing2latest 19 Aug 2026

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 2Aug 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why sildenafil is recalled

Companies

By year

2026233%
2020233%
2015117%
2014117%

Ongoing sildenafil recalls

2 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Sildenafil Citrate recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide

All sildenafil recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Sildenafil Citrate recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate USP, 100 gm recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
23 Dec 2020Drug	CLASS II	Sildenafil Tablets USP 100 mg recalled by AVKARE	Avkare	Hidden Drug Ingredients	Nationwide
5 Feb 2020Drug	CLASS II	Sildenafil 80 mg capsules recalled by MPRX	Mprx	Hidden Drug Ingredients	TX
20 May 2015Drug	CLASS II	Sildenafil 10 mg/ Susp, Health Innov Pharmacy recalled	Health Innovations Pharmacy	Sterility	NC
29 Jan 2014Drug	CLASS II	Sildenafil Citrate, Tablet, 25 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Sildenafil?

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.