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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 15,161–15,180 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01

by Novartis Pharmaceuticals Corp.

Reason
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Recall initiated
May 28, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46

by Ferring Pharmaceuticals Inc

Reason
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Recall initiated
April 28, 2014
Reported by FDA
June 25, 2014
Distribution
PA

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Drug Recall Terminated Historical recordClass II

Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1

by Thorne Research Inc

Reason
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Recall initiated
June 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.

View recall →

Drug Recall Terminated Historical recordClass II

Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5

by Thorne Research Inc

Reason
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Recall initiated
June 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.

View recall →

Drug Recall Terminated Historical recordClass II

Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated
May 12, 2014
Reported by FDA
June 25, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.

by Actavis Inc

Reason
Subpotent Drug.
Recall initiated
May 16, 2014
Reported by FDA
June 25, 2014
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.

by Cubist Pharmaceuticals, Inc.

Reason
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Recall initiated
April 17, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Recall initiated
May 23, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL

by MyNicNaxs, Inc.

Reason
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL

by MyNicNaxs, Inc.

Reason
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL

by MyNicNaxs, Inc.

Reason
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
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.