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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 13,641–13,660 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40

by The Apothecary Shoppe LLC

Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Oklahoma

View recall →

Drug Recall Terminated Historical recordClass II

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

by Ranbaxy Inc.

Reason
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Recall initiated
June 26, 2015
Reported by FDA
August 12, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108

by GlaxoSmithkline Consmer Healthcare

Reason
Failed Dissolution Specifications
Recall initiated
June 30, 2015
Reported by FDA
August 12, 2015
Distribution
Puerto Rico and Virgin Islands

View recall →

Drug Recall Terminated Historical recordClass III

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

by Perrigo Israel Pharmaceuticals

Reason
Subpotent drug
Recall initiated
July 13, 2015
Reported by FDA
August 12, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

by Actavis Laboratories, FL, Inc.

Reason
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Recall initiated
June 23, 2015
Reported by FDA
August 12, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.

by Shionogi Inc.

Reason
Failed Dissolution Specifications
Recall initiated
July 24, 2015
Reported by FDA
August 12, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Recall initiated
June 24, 2015
Reported by FDA
August 12, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

by Mutual Pharmaceutical Company, Inc.

Reason
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Recall initiated
July 9, 2015
Reported by FDA
August 5, 2015
Distribution
Nartionwide

View recall →

Drug Recall Terminated Historical recordClass II

Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.

by Mutual Pharmaceutical Company, Inc.

Reason
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Recall initiated
July 9, 2015
Reported by FDA
August 5, 2015
Distribution
Nartionwide

View recall →

Drug Recall Terminated Historical recordClass II

Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA

by Mutual Pharmaceutical Company, Inc.

Reason
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Recall initiated
July 9, 2015
Reported by FDA
August 5, 2015
Distribution
Nartionwide

View recall →

Drug Recall Terminated Historical recordClass II

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.

by Boehringer Ingelheim Roxane Inc

Reason
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Recall initiated
July 24, 2015
Reported by FDA
August 5, 2015
Distribution
Nationwide and Puerto Rico

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.