US Compounding Inc

FDA Regulatory Profile

US Compounding Inc has 65 FDA recalls (1 Class I), 4 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0223-2021 · Class III · Dec 16, 2020
Latest inspection
Feb 7, 2019 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls65 (1 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0223-2021Class IIISuccinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding…Dec 16, 2020
D-0175-2021Class IIINeostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US…Nov 25, 2020
D-0508-2019Class IIEphedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270…Jan 29, 2019
D-0482-2019Class IILET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe…Jan 24, 2019
D-0219-2017Class IDocusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02)…Jul 25, 2016
D-0276-2016Class IIPhenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US…Sep 12, 2015
D-0277-2016Class IIPhenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic…Sep 12, 2015
D-0245-2016Class IICyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use…Sep 12, 2015
D-0249-2016Class IIDex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL…Sep 12, 2015
D-0270-2016Class IIMorphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by…Sep 12, 2015
D-0286-2016Class IITriamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only…Sep 12, 2015
D-0269-2016Class IIMIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding…Sep 12, 2015
D-0289-2016Class IITropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only…Sep 12, 2015
D-0244-2016Class IICyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded…Sep 12, 2015
D-0247-2016Class IIDapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by…Sep 12, 2015
D-0253-2016Class IIGlycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only…Sep 12, 2015
D-0278-2016Class IIPilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding…Sep 12, 2015
D-0287-2016Class IITriamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only…Sep 12, 2015
D-0280-2016Class IISuccinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only…Sep 12, 2015
D-0240-2016Class IIBetamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only…Sep 12, 2015

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 7, 2019Conway, ARDrugsOfficial Action Indicated (OAI)3006031801
Jul 15, 2016Conway, ARDrugsOfficial Action Indicated (OAI)3006031801
Aug 21, 2015Conway, ARDrugsOfficial Action Indicated (OAI)3006031801
Mar 27, 2014Conway, ARDrugsVoluntary Action Indicated (VAI)3006031801

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3006031801Conway, AR4Feb 7, 2019

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.