FDA Drug recall D-0296-2025
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
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of 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… by Quva Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0296-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-06 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Quva Pharma |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Quva Pharma
- 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 - 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 - 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 - 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 - 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
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.