QuVa Pharma, Inc.
QuVa Pharma, Inc. appears in FDA public data with 38 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 15 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0664-2026, Class II) was initiated on June 24, 2026.
Summary
- Total Recalls
- 38 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 15
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0664-2026 | Class II | Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Ph | June 24, 2026 |
| D-0113-2026 | Class II | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chlorid | October 10, 2025 |
| D-0295-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml | March 6, 2025 |
| D-0296-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 10 | March 6, 2025 |
| D-0297-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml | March 6, 2025 |
| D-1544-2022 | Class III | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High A | September 20, 2022 |
| D-1302-2020 | Class II | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only | May 28, 2020 |
| D-1335-2020 | Class III | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL | April 23, 2020 |
| D-0572-2020 | Class II | fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA | November 12, 2019 |
| D-0563-2020 | Class II | fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuV | November 12, 2019 |
| D-0550-2020 | Class II | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium | November 12, 2019 |
| D-0553-2020 | Class II | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA | November 12, 2019 |
| D-0560-2020 | Class II | fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park | November 12, 2019 |
| D-0555-2020 | Class II | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 | November 12, 2019 |
| D-0546-2020 | Class II | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chlor | November 12, 2019 |
| D-0557-2020 | Class II | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium | November 12, 2019 |
| D-0561-2020 | Class II | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chlor | November 12, 2019 |
| D-0570-2020 | Class II | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park | November 12, 2019 |
| D-0547-2020 | Class II | fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodiu | November 12, 2019 |
| D-0554-2020 | Class II | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chlor | November 12, 2019 |