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

fentaNYL 1000 mcg/ (10 mcg/mL) recalled by QuVa Pharma

QuVa Pharma is recalling fentaNYL 1000 mcg/ (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma, 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: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031942 Exp. 12/26/2019 10031970 Exp. 12/29/2019 10031971 Exp. 12/29/2019 10031972 Exp. 12/29/2019 10031973 Exp. 12/29/2019 10032273 Exp. 12/30/2019 10032274 Exp. 12/30/2019 10032329 Exp. 12/31/2019 10032330 Exp. 12/31/2019 10032812 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032004 Exp. 12/27/2019 10032028 Exp. 12/27/2019 10032029 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032029 Exp. 12/27/2019 10032030 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10033353 Exp. 1/17/2020 10033352 Exp. 1/16/2020 10031753 Exp. 12/26/2019

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-0555-2020
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 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36

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: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031942 Exp. 12/26/2019 10031970 Exp. 12/29/2019 10031971 Exp. 12/29/2019 10031972 Exp. 12/29/2019 10031973 Exp. 12/29/2019 10032273 Exp. 12/30/2019 10032274 Exp. 12/30/2019 10032329 Exp. 12/31/2019 10032330 Exp. 12/31/2019 10032812 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032004 Exp. 12/27/2019 10032028 Exp. 12/27/2019 10032029 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032029 Exp. 12/27/2019 10032030 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10033353 Exp. 1/17/2020 10033352 Exp. 1/16/2020 10031753 Exp. 12/26/2019

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