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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 7,921–7,940 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10

by Advanced Pharma Inc.

Reason
Sub-potency
Recall initiated
April 26, 2019
Reported by FDA
May 8, 2019
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Recall initiated
April 24, 2019
Reported by FDA
May 8, 2019
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Recall initiated
April 24, 2019
Reported by FDA
May 8, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01

by LUPIN SOMERSET

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 10, 2019
Reported by FDA
May 1, 2019
Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

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Drug Recall Terminated Historical recordClass III

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01

by LUPIN SOMERSET

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 10, 2019
Reported by FDA
May 1, 2019
Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass III

Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01

by LUPIN SOMERSET

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 10, 2019
Reported by FDA
May 1, 2019
Distribution
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass III

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

by Zydus Pharmaceuticals USA Inc

Reason
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Recall initiated
April 22, 2019
Reported by FDA
May 1, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

by Akorn Inc

Reason
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Recall initiated
April 23, 2019
Reported by FDA
May 1, 2019
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

by CMC Enterprise Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 12, 2019
Reported by FDA
May 1, 2019
Distribution
NC

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.