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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 13,841–13,860 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

by Advanced Physician Solutions, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 18, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.

by Stroheckers Inc Pharmacy

Reason
Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
Recall initiated
April 12, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Recall initiated
May 7, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide and Peurto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for 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: One lot exceeded the mechanical peel specification
Recall initiated
January 12, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

by Boehringer Ingelheim Roxane Inc

Reason
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Recall initiated
April 2, 2015
Reported by FDA
June 3, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05

by Oasis Medical, Inc.

Reason
Failed pH specification
Recall initiated
April 10, 2015
Reported by FDA
May 27, 2015
Distribution
FL

View recall →

Drug Recall Terminated Historical recordClass III

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Recall initiated
March 26, 2015
Reported by FDA
May 27, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

by Health Innovations Pharmacy, Inc

Reason
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recall initiated
February 12, 2015
Reported by FDA
May 20, 2015
Distribution
NC

View recall →

Drug Recall Terminated Historical recordClass II

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01

by Alvogen, Inc

Reason
Failed Dissolution Specification; 6 month time point
Recall initiated
April 21, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

by Apotex Inc.

Reason
Subpotent drug
Recall initiated
April 7, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

by Apotex Inc.

Reason
Subpotent drug
Recall initiated
April 7, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide

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.