Compounded Drugs recalls

The FDA has published 721 recalls involving compounded drugs since 2012. The latest was reported on 19 Aug 2026. Most were for sterility. Main Street Family Pharmacy 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 recalls721since 2012

Last 12 months6reported

Class I101% of total

Ongoing78latest 19 Aug 2026

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 1Jul 5 0

Severity split

Class I 10 1%Class II 701 97%Class III 10 1%

Why compounded drugs is recalled

Companies

By year

202661%
2023527%
2022182%
2021395%
2019416%
2018416%
2017618%
201611816%
2015477%
2014335%

Ongoing compounded drugs recalls

78 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Tadalafil USP(1000gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate Usp-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(500gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(100gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate USP, 100 gm-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
15 Jul 2026Drug	CLASS II	Methohexital Sodium, 100 mg/ (10 mg/mL), Total Volume recalled	QuVa Pharma	Potency & Assay	Nationwide

All compounded drugs recalls, newest first

721 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Tadalafil USP(1000gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate Usp-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(500gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(100gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
19 Aug 2026Drug	CLASS II	Sildenafil Citrate USP, 100 gm-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem L	Hidden Drug Ingredients	Nationwide
15 Jul 2026Drug	CLASS II	Methohexital Sodium, 100 mg/ (10 mg/mL), Total Volume recalled	QuVa Pharma	Potency & Assay	Nationwide
27 Dec 2023Drug	CLASS II	Nystatin 150 MU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN
27 Dec 2023Drug	CLASS II	Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN
27 Dec 2023Drug	CLASS II	Nystatin 500 MU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN
27 Dec 2023Drug	CLASS II	Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN

Should you stop taking Compounded Drugs?

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.