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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 6,721–6,740 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

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 77478 NDC 70092-1180-79

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 Land, TX 77478 NDC 70092-1415-47

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 77478 NDC 70092-1098-44

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass 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 Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 70092-1097-43

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 Land, TX 77478 NDC 70092-1092-36

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 100 Sugar Land, TX 77478 NDC 70092-1093-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 Land, TX 77478 NDC 70092-1099-49

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass 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 Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass 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% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

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 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37

by QuVa Pharma, Inc.

Reason
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recall initiated
November 12, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 22, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 22, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

by Sanofi-Aventis U.S. LLC

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 22, 2019
Reported by FDA
December 11, 2019
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.