CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report

fentaNYL 800 mcg/ (4 mcg/mL) BUPivacaine HCl recalled by QuVa Pharma

QuVa Pharma is recalling fentaNYL 800 mcg/ (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/ (1.667 mg/mL) in 0.9%, distributed nationwide in the US. The recall was initiated on 12 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0568-2020
FDA event ID: 84263
Recalling firm: QuVa Pharma, Sugar Land, TX
Classification: Class II
Status: Terminated
Recall initiated: 12 Nov 2019
FDA classified: 3 Dec 2019
Reported: 11 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Pain Medication

Timeline

12 Nov 2019	Recall initiated by company
3 Dec 2019	Classified by FDA	+21 days
11 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Product as listed by the FDA

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Which lots are affected?

Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020

Where was it sold?

Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

26 other products · FDA event 84263

This product is part of a recall event; the main page for the event is fentaNYL 2000 mcg/ (20 mcg/mL) in 0.9% Sodium Chloride recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2019	CLASS II	fentaNYL 2000 mcg/ (20 mcg/mL) in 0.9% Sodium Chloride recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 2750 mcg/ (50 mcg/mL) Syringe, Preservative Free recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 2500 mcg/ (50 mcg/mL), Preservative Free, Rx recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1250 mcg/ (5 mcg/mL) recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 550 mcg/ (10 mcg/mL) recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 400 mcg/ (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 400 mcg/ (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 500 mcg/ (2 mcg/mL) 0.125% BUPivacaine HCl recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1000 mcg/ (10 mcg/mL) recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1000 mcg/ (50 mcg/mL) in Syringe Preservative Free recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 250 mcg/ (50 mcg/mL) Syringe, Preservative Free recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 2500 mcg/ (10 mcg/mL) recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 100 mcg/ (50 mcg/mL) Preservative Free, Rx recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1000 mcg/ (10 mcg/mL) recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1500 mcg/ (50 mcg/mL) in Syringe Preservative Free recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 500 mcg/ (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 400 mcg/ (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 500 mcg/ (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 1500 mcg/ (50 mcg/mL) PCA Vial Preservative Free recalled	QuVa Pharma	Particulate Matter	Nationwide
11 Dec 2019	CLASS II	fentaNYL 500 mcg/ (2 mcg/mL) BUPivacaine HCl recalled by QuVa Pharma	QuVa Pharma	Particulate Matter	Nationwide

More recalls from QuVa Pharma

All 38

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Drug	CLASS II	Methohexital Sodium, 100 mg/ (10 mg/mL), Total Volume recalled	QuVa Pharma	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl recalled	QuVa Pharma	Particulate Matter	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide

Other Fentanyl recalls

All 248

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS II	fentaNYL Citrate, 1,000 mcg recalled by OurPharma	OurPharma	Other	Nationwide
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, CII recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide