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

Severity split

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

Why us compounding is recalled

By year

All us compounding recalls, newest first

65 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIISuccinylcholine Chloride PF Inj recalled by US CompoundingUS CompoundingOtherNationwide
DrugCLASS IIINeostigmine Methylsulfate PF Inj recalled by US CompoundingUS CompoundingLabeling ErrorsNationwide
DrugCLASS IIEphedrine Sulfate, 50 mg/ Single Use Syringe recalled by US CompoundingUS CompoundingSterilityNationwide
DrugCLASS IILET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + recalledUS CompoundingOtherNationwide
DrugCLASS IDocusate Oral 10 mg/mL Oral Syringe recalled by US CompoundingUS CompoundingSterilityTX
DrugCLASS IIFentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalledUS CompoundingSterilityNationwide
DrugCLASS IIMethylPREDNISolone PF (80 mg/mL) Single Use Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIDex LA 8 (Dexamethasone acetate (8 mg/mL) Multi-Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIMethylprednisolone/Lidocaine (40 mg/mL/1%) Multi-Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIMIC-Combo Multi-Dose Vial, For Deep IM Injection Only recalledUS CompoundingSterilityNationwide
DrugCLASS IITestosterone cypionate, USP (250 mg/mL) Multi-Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIVitamin D3 in Olive Oil (50,000 IU/mL) vial, For IM Use only recalledUS CompoundingSterilityNationwide
DrugCLASS IIPhenylephrine (1 mg/mL) Multi-Dose Vial, For SC, IM recalledUS CompoundingSterilityNationwide
DrugCLASS IIOmnipaque 300 (600 mg/ Single Use Vial (300 mg/mL) recalledUS CompoundingSterilityNationwide
DrugCLASS IIBetamethasone SP PF (12 mg/mL) Single Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IITropicamide 1%/Phenylephrine recalled by US CompoundingUS CompoundingSterilityNationwide
DrugCLASS IICyclopent/PE/Tropic (1%/2.5%/0.25%) dropper recalled by US CompoundingUS CompoundingSterilityNationwide
DrugCLASS IIHyaluronic Acid/Lidocaine PF (60 mg/2%) Single Use Syringe recalledUS CompoundingSterilityNationwide
DrugCLASS IILidocaine 1% PF(100 mg/ Single Use Syringe, For IV Injection recalledUS CompoundingSterilityNationwide
DrugCLASS IIMethylcobalamin (12.5 mg/mL) Multi-Dose Vial, For IM or SC Injection recalledUS CompoundingSterilityNationwide
DrugCLASS IIBetamethasone Combo PF (6 mg/mL) Multi-Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIDexamethasone Sodium Phosphate PF recalled by US CompoundingUS CompoundingSterilityNationwide
DrugCLASS IITestosterone EO-Pro-Cyp 220 (220 mg/mL) Multi-Dose Vial recalledUS CompoundingSterilityNationwide
DrugCLASS IIPhenylephrine 10% PF Ophthalmic Solution dropper recalledUS CompoundingSterilityNationwide
DrugCLASS IIZinc Sulfate (1 mg/mL) Single Dose Vial, For IV Use After Dilution recalledUS CompoundingSterilityNationwide
DrugCLASS IIHyaluronidase PF/mL) in Single-Use Vial, Not for IV Use recalledUS CompoundingSterilityNationwide
DrugCLASS IIHyaluronic Acid/Lidocaine PF (20 mg/1%) Single-Use Syringe recalledUS CompoundingSterilityNationwide
DrugCLASS IISuccinylcholine Chloride (200 mg/ Single Use Syringe recalledUS CompoundingSterilityNationwide
DrugCLASS IICholine chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin recalledUS CompoundingSterilityNationwide
DrugCLASS IIAcetylcysteine 10% Ophtalmic dropper recalled by US CompoundingUS CompoundingSterilityNationwide

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.