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

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 1 5Aug 0 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	Manufacturing (CGMP) Deviations	Nationwide
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	Tadalafil USP(500gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(100gm)-bag 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
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	Manufacturing (CGMP) Deviations	Nationwide
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	Tadalafil USP(500gm)-bag recalled by Shoolin Pharma Chem L	Shoolin Pharma Chem	Manufacturing (CGMP) Deviations	Nationwide
19 Aug 2026Drug	CLASS II	Tadalafil USP(100gm)-bag 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
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
25 Oct 2023Drug	CLASS II	Calcium Gluconate 2.5% solution for inhalation pre-filled syringes recalled	Pine Pharmaceuticals	Sterility	Nationwide
25 Oct 2023Drug	CLASS II	Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled	Pine Pharmaceuticals	Sterility	Nationwide
25 Oct 2023Drug	CLASS II	Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals	Pine Pharmaceuticals	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	rocuronium, 50 mg/, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	Cardioplegia Solution, 24 mEq K, Maintenance 8:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	Cardioplegia Solution, 20 mEq K, Maintenance 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	Cardioplegia Solution, 60 mEq K, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	Cardioplegia Solution, High K, Induction 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	rocuronium, 50 mg /, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	Cardioplegia Solution, 15 mEq K, Reperfusate 4:1 recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	SUCCINYLcholine Chloride 200 mg/ (20 mg/mL) BD Syringe recalled	New England Life Care	Manufacturing (CGMP) Deviations	Nationwide
26 Jul 2023Drug	CLASS II	ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled	New England Life Care	Manufacturing (CGMP) Deviations	Nationwide
31 May 2023Drug	CLASS II	Modified del Nido Microplegia recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	Cardioplegia Solution, Leesburg Cardioplegia recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	Cardioplegia Solution, del Nido Formula recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	Cardioplegia Solution, Modified St Thomas Solution recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	tromethamine 0.3 Molar syringe recalled by Central Admixture Pharmacy	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	Cardioplegia Solution, Induction 4:1 Plasmalyte recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
31 May 2023Drug	CLASS II	Cardioplegia Solution, Maintenance 8:1 non-enriched recalled	Central Admixture Pharmacy Services	Sterility	Nationwide

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.