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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 7,941–7,960 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

CeFAZolin 1 GM a) in NS 100 mL bag; b) 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 →

Drug Recall Terminated Historical recordClass II

Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, 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

Alteplase 1 mg/mL 1 mL in 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 →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 units in NS 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

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 16 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

NICARdipine 25 mg in NS 250 mL EXCEL 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

Magnesium Sulfate 6 GM in NS 50 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

Magnesium Sulfate 4 GM in NS 50 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

Magnesium Sulfate 1 GM in NS 50 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

Labetalol 20 mg/4 mL, 20 mg in 4 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

Diltiazem 250 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

Clindamycin 900 mg in NS 50 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 III

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01

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, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01

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 II

DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, 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

Chlorothiazide 100 mg, 3.57 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

CeFAZolin 3 gm 100 mg/mL, 30 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

CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 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

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, 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

Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, 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.