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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 11,741–11,760 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated
May 5, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated
May 5, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11

by PharMEDium Services, LLC

Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated
May 5, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

by West-Ward Columbus Inc

Reason
Failed Impurities/Degradation Specification; 9 month stability
Recall initiated
May 19, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Recall initiated
December 21, 2015
Reported by FDA
July 20, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Recall initiated
December 21, 2015
Reported by FDA
July 20, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Recall initiated
December 21, 2015
Reported by FDA
July 20, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

by Apotex Scientific, Inc

Reason
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Recall initiated
January 26, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide, Alaska, Hawaii, and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

by Apotex Scientific, Inc

Reason
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Recall initiated
January 26, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide, Alaska, Hawaii, and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

by Apotex Scientific, Inc

Reason
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Recall initiated
January 26, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide, Alaska, Hawaii, and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

by Hospira Inc.

Reason
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Recall initiated
June 23, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.

by Murray International Trading Co., Inc.

Reason
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
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.