Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 11,401–11,420 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90

by Burel Pharmaceuticals Inc

Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recall initiated
October 24, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977

by Par Pharmaceutical, Inc.

Reason
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Recall initiated
October 5, 2016
Reported by FDA
December 7, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

by West-Ward Pharmaceuticals Corp.

Reason
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Recall initiated
October 3, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Recall initiated
November 1, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY

by Akorn Inc

Reason
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Recall initiated
November 14, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: OOS results for known compound.
Recall initiated
November 3, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01

by Pfizer Inc.

Reason
Superpotent
Recall initiated
November 7, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05

by Zydus Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Recall initiated
August 3, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Recall initiated
October 28, 2016
Reported by FDA
November 30, 2016
Distribution
NJ and further distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01

by West-Ward Pharmaceuticals Corp.

Reason
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Recall initiated
November 4, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

by VistaPharm, Inc.

Reason
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Recall initiated
November 9, 2016
Reported by FDA
November 30, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01

by Sandoz Inc

Reason
Labeling: Missing Label
Recall initiated
October 19, 2016
Reported by FDA
November 30, 2016
Distribution
WI

View recall →

Drug Recall Terminated Historical recordClass III

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217

by Amerisource Health Services

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
October 13, 2016
Reported by FDA
November 30, 2016
Distribution
US

View recall →

Drug Recall Terminated Historical recordClass III

NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10

by Actavis Elizabeth LLC

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
October 6, 2016
Reported by FDA
November 30, 2016
Distribution
US

View recall →

Drug Recall Terminated Historical recordClass III

Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01

by GSK Consumer Healthcare

Reason
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Recall initiated
October 18, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.

by Sandoz Inc

Reason
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recall initiated
November 9, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide throughout the USA

View recall →

Drug Recall Terminated Historical recordClass II

L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recall initiated
November 9, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide throughout the USA

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.