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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 14,981–15,000 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recall initiated
March 24, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013

by Sage Products Inc

Reason
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Recall initiated
August 27, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Recall initiated
August 27, 2014
Reported by FDA
September 10, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall initiated
April 21, 2014
Reported by FDA
September 3, 2014
Distribution
United States: TX, IL, MD, IN

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Drug Recall Terminated Historical recordClass II

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall initiated
April 21, 2014
Reported by FDA
September 3, 2014
Distribution
United States: TX, IL, MD, IN

View recall →

Drug Recall Terminated Historical recordClass I

Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall initiated
April 21, 2014
Reported by FDA
September 3, 2014
Distribution
United States: TX, IL, MD, IN

View recall →

Drug Recall Terminated Historical recordClass I

Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall initiated
April 21, 2014
Reported by FDA
September 3, 2014
Distribution
United States: TX, IL, MD, IN

View recall →

Drug Recall Terminated Historical recordClass II

All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX

by Abrams Royal Pharamacy

Reason
Lack of Assurance of Sterility
Recall initiated
December 19, 2013
Reported by FDA
September 3, 2014
Distribution
Nationwide and to Canada

View recall →

Drug Recall Terminated Historical recordClass I

MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

by Abrams Royal Pharamacy

Reason
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Recall initiated
December 19, 2013
Reported by FDA
September 3, 2014
Distribution
Nationwide and to Canada

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Drug Recall Terminated Historical recordClass I

LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

by Central Admixture Pharmacy Services, Inc.

Reason
Non Sterility; microbial contamination identified as Aspergillus species
Recall initiated
May 28, 2014
Reported by FDA
September 3, 2014
Distribution
Michigan and Wisconsin

View recall →

Drug Recall Terminated Historical recordClass I

adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

by Central Admixture Pharmacy Services, Inc.

Reason
Non Sterility; microbial contamination identified as Aspergillus species
Recall initiated
May 28, 2014
Reported by FDA
September 3, 2014
Distribution
Michigan and Wisconsin

View recall →

Drug Recall Terminated Historical recordClass I

del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

by Central Admixture Pharmacy Services, Inc.

Reason
Non Sterility; microbial contamination identified as Aspergillus species
Recall initiated
May 28, 2014
Reported by FDA
September 3, 2014
Distribution
Michigan and Wisconsin

View recall →

Drug Recall Terminated Historical recordClass I

PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

by Central Admixture Pharmacy Services, Inc.

Reason
Non Sterility; microbial contamination identified as Aspergillus species
Recall initiated
May 28, 2014
Reported by FDA
September 3, 2014
Distribution
Michigan and Wisconsin

View recall →

Drug Recall Terminated Historical recordClass III

Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02.

by Perrigo Holland Inc

Reason
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Recall initiated
August 19, 2014
Reported by FDA
September 3, 2014
Distribution
U.S. Distribution: OH, RI, OR, PA, MN, IL, AR.

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.