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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 13,101–13,120 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527

by Diabetes Corporation of America dba DCA Pharmacy

Reason
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Recall initiated
September 23, 2015
Reported by FDA
October 14, 2015
Distribution
KY, OH, TN

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Drug Recall Terminated Historical recordClass III

Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.

by Apotex Inc.

Reason
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Recall initiated
July 21, 2015
Reported by FDA
October 7, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix (Papaverine/ Aloprostadil/ Phentolamine) Products, 5) All Testosterone Products, 6) All Dexamethasone Products, 7) All Levocarnitine Products, 8) All Hydroxyprogesterone Caproate Products, 9) All Triamcinolone Products, 10) All Betamethasone Sodium Phosphate Products, 11) All Methylprednisolone Acetate Products.

by Medistat RX L.L.C.

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2015
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244

by Eagle Pharmacy, Inc.

Reason
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Recall initiated
August 28, 2015
Reported by FDA
October 7, 2015
Distribution
TN, AL

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Drug Recall Terminated Historical recordClass III

METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.

by VistaPharm, Inc.

Reason
Defective Container: Lids on unit dose cups are not fully qualified.
Recall initiated
June 26, 2015
Reported by FDA
October 7, 2015
Distribution
U.S. Including: CA, IL, LA, OH, PA, and SC.

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Drug Recall Terminated Historical recordClass I

Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888

by Hartley Medical Center Pharmacy, Incorporated

Reason
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Recall initiated
August 17, 2015
Reported by FDA
October 7, 2015
Distribution
CA and NV

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Drug Recall Terminated Historical recordClass I

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888

by Hartley Medical Center Pharmacy, Incorporated

Reason
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Recall initiated
August 17, 2015
Reported by FDA
October 7, 2015
Distribution
CA and NV

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Drug Recall Terminated Historical recordClass III

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

by Guthy-Renker LLC

Reason
Subpotent Drug: Salicylic acid is subpotent.
Recall initiated
May 7, 2012
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide including Puerto Rico and Guam; Canada.

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Drug Recall Terminated Historical recordClass III

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

by Guthy-Renker LLC

Reason
Subpotent Drug: Salicylic acid is subpotent.
Recall initiated
May 7, 2012
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide including Puerto Rico and Guam; Canada.

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Drug Recall Terminated Historical recordClass III

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

by Guthy-Renker LLC

Reason
Subpotent Drug: Salicylic acid is subpotent.
Recall initiated
May 7, 2012
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide including Puerto Rico and Guam; Canada.

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Drug Recall Terminated Historical recordClass III

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

by Guthy-Renker LLC

Reason
Subpotent Drug: Salicylic acid is subpotent.
Recall initiated
May 7, 2012
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide including Puerto Rico and Guam; Canada.

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Drug Recall Terminated Historical recordClass III

Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.

by Guthy-Renker LLC

Reason
Subpotent Drug: Salicylic acid is subpotent.
Recall initiated
May 7, 2012
Reported by FDA
October 7, 2015
Distribution
U.S. Nationwide including Puerto Rico and Guam; Canada.

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Drug Recall Terminated Historical recordClass I

PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Recall initiated
January 28, 2015
Reported by FDA
September 30, 2015
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.