Quva Pharma recalls
Quva Pharma appears in 38 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 38 |
|---|---|
| Published | 2016-07-13 to 2026-07-15 |
| By agency | FDA Drug (38) |
| By classification | Class II (33), Class III (3), Class I (2) |
| By status | terminated (33), ongoing (5) |
| Distribution named in notices | CA, US |
Recalls
- 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, Su…
FDA Drug · Class II · 2026-07-15 · Quva Pharma
Reason: Failed Impurities/Degradation Specifications - R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe
FDA Drug · Class II · 2025-11-05 · Quva Pharma
Reason: Presence of Particulate Matter - 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…
FDA Drug · Class II · 2025-04-02 · Quva Pharma
Reason: Lack of Assurance of Sterility - 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 E…
FDA Drug · Class II · 2025-04-02 · Quva Pharma
Reason: Lack of Assurance of Sterility - 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 E…
FDA Drug · Class II · 2025-04-02 · Quva Pharma
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class III · 2022-10-05 · Quva Pharma
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). - R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloomb…
FDA Drug · Class III · 2020-07-01 · Quva Pharma
Reason: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac - 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,…
FDA Drug · Class II · 2020-06-17 · Quva Pharma
Reason: Subpotent drug - Product did not contain drug. - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 W…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharm…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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,…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 10…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 1…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx,…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 Lan…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 Pres…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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, Suit…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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, R…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 77…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 L…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 70092-109…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 7747…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 77…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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,…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 1…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - 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 Lan…
FDA Drug · Class II · 2019-12-11 · Quva Pharma
Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules - Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One…
FDA Drug · Class III · 2018-12-19 · Quva Pharma
Reason: Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride - Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804…
FDA Drug · Class I · 2018-09-26 · Quva Pharma
Reason: Subpotent Drug: Product may not have the active ingredient present in the bag. - PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Th…
FDA Drug · Class I · 2016-07-13 · Quva Pharma
Reason: Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.