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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 14,681–14,700 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

by Fresenius Kabi USA LLC

Reason
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Recall initiated
April 14, 2014
Reported by FDA
November 19, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Recall initiated
August 19, 2014
Reported by FDA
November 19, 2014
Distribution
NY

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Drug Recall Terminated Historical recordClass II

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

by Fougera Pharmaceuticals Inc.

Reason
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Recall initiated
August 28, 2014
Reported by FDA
November 19, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

SODIUM CHLORIDE INHALATION, 7%, Solution for inhalation, 3 mL plastic vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass II

GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

View recall →

Drug Recall Terminated Historical recordClass II

CALCIUM CHLORIDE (COMPOUND), 100 mg/mL, Injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass II

AVASTIN, 1.25mg/0.5mL, injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
October 6, 2014
Reported by FDA
November 12, 2014
Distribution
Oregon, Washington

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recall initiated
October 16, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recall initiated
October 16, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recall initiated
October 16, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Recall initiated
October 16, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

by Pharmaceutical Associates Inc

Reason
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Recall initiated
October 16, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

by Physicians Total Care, Inc.

Reason
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Recall initiated
September 11, 2013
Reported by FDA
November 12, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ

by Nanophase Technologies Corporation

Reason
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Recall initiated
October 20, 2014
Reported by FDA
November 12, 2014
Distribution
NJ

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Drug Recall Terminated Historical recordClass II

CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233

by Physicians Total Care, Inc.

Reason
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Recall initiated
September 22, 2014
Reported by FDA
November 12, 2014
Distribution
Distributed in Georgia and Missouri.

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Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

by Sun Pharma Global Inc.

Reason
Failed Dissolution Specifications; 12 month stability time point
Recall initiated
September 26, 2014
Reported by FDA
November 12, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; NDC 0008-1179-01.

by Pfizer Inc.

Reason
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Recall initiated
October 10, 2014
Reported by FDA
November 12, 2014
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.