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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 17,081–17,100 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Recall initiated
February 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico, and Panama. Military distribution made.

View recall →

Drug Recall Terminated Historical recordClass III

Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Recall initiated
February 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico, and Panama. Military distribution made.

View recall →

Drug Recall Terminated Historical recordClass III

Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Recall initiated
February 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico, and Panama. Military distribution made.

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

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.