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QuVa Pharma, Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20161
20182
201927
20202
20221
20254
20261
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FDA Recall Ongoing 2026 recordClass II

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.

by QuVa Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
July 15, 2026
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Presence of Particulate Matter
Published
November 5, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Published
April 2, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Published
April 2, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Lack of Assurance of Sterility
Published
April 2, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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.

by QuVa Pharma, Inc.

Reason
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).
Published
October 5, 2022
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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

by QuVa Pharma, Inc.

Reason
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Published
July 1, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Subpotent drug - Product did not contain drug.
Published
June 17, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Published
December 11, 2019
Distribution
Nationwide

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This page lists recalls that name QuVa Pharma, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.