thejoe QuVa Pharma, Inc.

QuVa Pharma, Inc.: 38 FDA recall reports

Every drug recall the FDA has published for QuVa Pharma, Inc.. The fault, and how the agency graded it.

38Reports

2Class I

5Ongoing

2026-07-15Most recent

2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	33
Class III	3
Class I	2

By year reported

Year	Reports
2016	1
2018	2
2019	27
2020	2
2022	1
2025	4
2026	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075

D-0664-2026 · Class II · reported 2026-07-15 · Ongoing

Why it was recalled: Failed Impurities/Degradation Specifications
Product: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Where it went: Nationwide within the United States
How much: N/A

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution

D-0113-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Presence of Particulate Matter
Product: R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
Where it went: U.S. Nationwide
How much: 75,885 syringes

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS

D-0296-2025 · Class II · reported 2025-04-02 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Where it went: U.S. Nationwide
How much: 2,310 cassettes

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yell

D-0295-2025 · Class II · reported 2025-04-02 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Where it went: U.S. Nationwide
How much: N/A

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yell

D-0297-2025 · Class II · reported 2025-04-02 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
Where it went: U.S. Nationwide
How much: 1,765 cassettes

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This

D-1544-2022 · Class III · reported 2022-10-05 · Terminated

Why it was recalled: Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Product: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
Where it went: Nationwide in the USA
How much: 1994 bags

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe,

D-1335-2020 · Class III · reported 2020-07-01 · Terminated

Why it was recalled: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Product: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
Where it went: Distributed Nationwide in the US.
How much: 17,050 syringes

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pha

D-1302-2020 · Class II · reported 2020-06-17 · Terminated

Why it was recalled: Subpotent drug - Product did not contain drug.
Product: oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
Where it went: USA Nationwide
How much: 648 bags

fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1

D-0563-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36
Where it went: Nationwide.

fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive

D-0558-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50
Where it went: Nationwide.

fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Su

D-0569-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Where it went: Nationwide.

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL

D-0548-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
Where it went: Nationwide.

fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075

D-0567-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
Where it went: Nationwide.

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100

D-0561-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36
Where it went: Nationwide.

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 Chlori

D-0568-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: 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 went: Nationwide.

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 10

D-0572-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
Where it went: Nationwide.

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL

D-0564-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
Where it went: Nationwide.

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preser

D-0565-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Where it went: Nationwide.

fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200

D-0562-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
Where it went: Nationwide.

fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride

D-0547-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37
Where it went: Nationwide.

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park

D-0555-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: 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 went: Nationwide.

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride P

D-0550-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
Where it went: Nationwide.

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park O

D-0566-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
Where it went: Nationwide.

fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive,

D-0560-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
Where it went: Nationwide.

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 107

D-0553-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
Where it went: Nationwide.

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL

D-0559-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75
Where it went: Nationwide.

fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sug

D-0556-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
Where it went: Nationwide.

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 10

D-0571-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75
Where it went: Nationwide.

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park O

D-0551-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49
Where it went: Nationwide.

fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL

D-0552-2020 · Class II · reported 2019-12-11 · Terminated

Why it was recalled: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
Where it went: Nationwide.

Showing the 30 most recent of 38. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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