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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 9,481–9,500 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Recall initiated
June 14, 2018
Reported by FDA
July 11, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass III

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

by Qualgen, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date.
Recall initiated
June 8, 2018
Reported by FDA
July 11, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

by Qualgen, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date.
Recall initiated
June 8, 2018
Reported by FDA
July 11, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

by Ingenus Pharmaceuticals Llc

Reason
Superpotent Drug: High out of specification assay value results for potency.
Recall initiated
June 8, 2018
Reported by FDA
July 11, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

by Ingenus Pharmaceuticals Llc

Reason
Superpotent Drug: High out of specification assay value results for potency.
Recall initiated
June 8, 2018
Reported by FDA
July 11, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.

by Advanced Pharma Inc.

Reason
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Recall initiated
June 20, 2018
Reported by FDA
July 4, 2018
Distribution
Distributed to one medical center in Fort Worth, TX.

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 12, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 12, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 12, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide in the USA and Puerto Rico

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.