Public Health Trace

Get Alerts

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.

Filters

Drug Recall Terminated Historical recordClass II

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.

by SCA Pharmaceuticals

Reason: Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated: July 14, 2017
Reported by FDA: August 2, 2017
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02

by Valeant Pharmaceuticals North America LLC

Reason: Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Recall initiated: June 28, 2017
Reported by FDA: July 26, 2017
Distribution: U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65

by PharMEDium Services, LLC

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer
Recall initiated: June 26, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Recall initiated: June 29, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Recall initiated: June 29, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981

by Shionogi Inc.

Reason: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Recall initiated: May 24, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30

by Shionogi Inc.

Reason: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Recall initiated: May 24, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

by Hospira Inc., A Pfizer Company

Reason: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Recall initiated: July 6, 2017
Reported by FDA: July 26, 2017
Distribution: Nationwide

View recall →

Data last updated: September 24, 2026 ET

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.