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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 7,961–7,980 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate 2 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

Dexmedetomidine 400 mcg in NS 100 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

Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.

by Johnson Matthey Inc.

Reason
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Product was distributed to one manufacturer in Morgantown, WV who may have manufactured the product into finished product and further distribute to the retail level Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.

by Brian P. Richardson

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Recall initiated
April 5, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Recall initiated
April 12, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 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.