QuVa Pharma, Inc.
Complete recall history across all FDA and CPSC categories — 37 total recalls
QuVa Pharma, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (37)
FDA drug safety enforcement actions by QuVa Pharma, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 10, 2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... | Presence of Particulate Matter | Class II |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... | Lack of Assurance of Sterility | Class II |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... | Lack of Assurance of Sterility | Class II |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... | Lack of Assurance of Sterility | Class II |
| Sep 20, 2022 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injec... | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.... | Class III |
| May 28, 2020 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject... | Subpotent drug - Product did not contain drug. | Class II |
| Apr 23, 2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... | Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac | Class III |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuV... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free,... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Pres... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 W... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Prese... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free,... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Fre... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Pres... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preser... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Ph... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuV... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 12, 2019 | fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Pre... | Presence of Particulate matter: manufacturer recalled fentanyl API due to pot... | Class II |
| Nov 21, 2018 | Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... | Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of ... | Class III |
| Aug 27, 2018 | Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative ... | Subpotent Drug: Product may not have the active ingredient present in the bag. | Class I |
| Mar 30, 2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,... | Labeling: Label Error on Declared Strength. Product has correct label on the ... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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