Sildenafil recalls
The FDA has published 4 recalls involving Sildenafil since 2018. The latest was reported on 19 Aug 2026. Most were for hidden drug ingredients. Shoolin Pharma Chem L 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 recalls4since 2018
Last 12 months2reported
Class I00% of total
Ongoing2latest 19 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 100%Class III 0 0%
Why sildenafil is recalled
Companies
By year
Ongoing sildenafil recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sildenafil Citrate Usp-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem L | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Sildenafil Citrate USP, 100 gm-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem L | Hidden Drug Ingredients | Nationwide |
All sildenafil recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sildenafil Citrate Usp-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem L | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Sildenafil Citrate USP, 100 gm-bag recalled by Shoolin Pharma Chem L | Shoolin Pharma Chem L | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Sildenafil Tablets USP 100 mg recalled by AVKARE | AVKARE | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Sildenafil Citrate USP for prescription compounding recalled | American Pharmaceutical Ingredients | Hidden Drug Ingredients | Nationwide |
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.