Is Fentanyl recalled?

356 FDA recalls mention Fentanyl. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Fentanyl.

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1093-37 D-0553-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1225-37 D-0552-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1099-49 D-0551-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1104-36 D-0550-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1269-37 D-0549-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1259-75 D-0548-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1105-37 D-0547-2020

Class II · Moderate risk Terminated Nov 12, 2019

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…

Reason Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

QuVa Pharma, Inc. NDC 70092-1160-37 D-0546-2020

Class II · Moderate risk Terminated Oct 9, 2019

PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200…

Reason GMP Deviations: potential glass contamination

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center D-0149-2020

Class II · Moderate risk Terminated Oct 9, 2019

PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500…

Reason GMP Deviations: potential glass contamination

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center D-0148-2020

Class II · Moderate risk Terminated Oct 9, 2019

PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3…

Reason GMP Deviations: potential glass contamination

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center NDC 69374-0525-25 D-0147-2020

Class II · Moderate risk Terminated Sep 12, 2019

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

Reason CGMP Deviations: Received notice from supplier that there is potential glass contamination.

Spectrum Laboratory Products NDC 49452-0032-06 D-0141-2020

Class II · Moderate risk Terminated Sep 12, 2019

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0051-2020

Class II · Moderate risk Terminated Sep 12, 2019

fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0050-2020

Class II · Moderate risk Terminated Sep 12, 2019

fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0049-2020

Class II · Moderate risk Terminated Sep 3, 2019