US Compounding recalls

US Compounding has 65 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 20 Jan 2021. The most frequent reason is sterility.

Total recalls65since 2014

Last 12 months0reported

Class I12% of total

Ongoing0latest 20 Jan 2021

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 0Jul 0 0

Severity split

Class I 1 2%Class II 62 95%Class III 2 3%

Why us compounding is recalled

Product types

By year

202123%
201923%
201612%
20155991%
201412%

All us compounding recalls, newest first

65 total

Reported	Class	Recall	Company	Reason	Where
20 Jan 2021Drug	CLASS III	Succinylcholine Chloride PF Inj recalled by US Compounding	US Compounding	Other	Nationwide
6 Jan 2021Drug	CLASS III	Neostigmine Methylsulfate PF Inj recalled by US Compounding	US Compounding	Labeling Errors	Nationwide
27 Feb 2019Drug	CLASS II	Ephedrine Sulfate, 50 mg/ Single Use Syringe recalled by US Compounding	US Compounding	Sterility	Nationwide
20 Feb 2019Drug	CLASS II	LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 05% + recalled	US Compounding	Other	Nationwide
28 Dec 2016Drug	CLASS I	Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding	US Compounding	Sterility	TX
25 Nov 2015Drug	CLASS II	Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalled	US Compounding	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	MethylPREDNISolone PF (80 mg/mL) Single Use Vial recalled	US Compounding	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	Dex LA 8 (Dexamethasone acetate (8 mg/mL) Multi-Dose Vial recalled	US Compounding	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	Methylprednisolone/Lidocaine (40 mg/mL/1%) Multi-Dose Vial recalled	US Compounding	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	MIC-Combo Multi-Dose Vial, For Deep IM Injection Only recalled	US Compounding	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.