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

ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated: July 26, 2013
Reported by FDA: September 18, 2013
Distribution: USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30

by Hospira Inc.

Reason: Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Recall initiated: August 14, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409

by Qualitest Pharmaceuticals

Reason: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Recall initiated: August 8, 2013
Reported by FDA: September 18, 2013
Distribution: Natiowide

View recall →

Drug Recall Terminated Historical recordClass II

K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409

by Qualitest Pharmaceuticals

Reason: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Recall initiated: August 8, 2013
Reported by FDA: September 18, 2013
Distribution: Natiowide

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627

by Wellness Pharmacy, Inc.

Reason: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869

by Pharmacy Creations

Reason: Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Recall initiated: August 26, 2013
Reported by FDA: September 18, 2013
Distribution: NJ

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.

by Pharmacy Creations

Reason: Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Recall initiated: August 26, 2013
Reported by FDA: September 18, 2013
Distribution: NJ

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason: Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: CA, IN

View recall →

Drug Recall Terminated Historical recordClass II

Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason: Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: CA, IN

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA

by South Coast Specialty Compounding, Inc.

Reason: Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Recall initiated: August 23, 2013
Reported by FDA: September 18, 2013
Distribution: CA, IN

View recall →

Data last updated: October 3, 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.