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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 11,421–11,440 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03

by CutisPharma, Inc.

Reason
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Recall initiated
October 20, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05

by CutisPharma, Inc.

Reason
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Recall initiated
October 20, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories

by Amerisource Health Services

Reason
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Recall initiated
October 27, 2016
Reported by FDA
November 23, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20

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

Reason
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Recall initiated
September 28, 2016
Reported by FDA
November 16, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505

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

Reason
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Recall initiated
September 28, 2016
Reported by FDA
November 16, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Recall initiated
May 26, 2016
Reported by FDA
November 16, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054

by Sandoz Inc

Reason
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Recall initiated
August 24, 2016
Reported by FDA
November 16, 2016
Distribution
TN

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Drug Recall Terminated Historical recordClass III

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass II

Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass III

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass III

Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass III

Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass II

Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network

by Wells Pharmacy Network, LLC

Reason
Superpotent and Subpotent drugs
Recall initiated
September 19, 2016
Reported by FDA
November 16, 2016
Distribution
U.S.

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Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.

by PharMEDium Services, LLC

Reason
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Recall initiated
October 12, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

by Akorn Inc

Reason
Subpotent Drug: concentration of product is less than labeled amount.
Recall initiated
October 21, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Completed Historical recordClass III

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

by Par Pharmaceutical, Inc.

Reason
Subpotent Drug; Ethinyl Estradiol
Recall initiated
September 27, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass III

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

by Par Pharmaceutical, Inc.

Reason
Subpotent Drug; Ethinyl Estradiol
Recall initiated
September 27, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass III

Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

by Par Pharmaceutical, Inc.

Reason
Subpotent Drug; Ethinyl Estradiol
Recall initiated
September 27, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass III

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

by Par Pharmaceutical, Inc.

Reason
Subpotent Drug; Ethinyl Estradiol
Recall initiated
September 27, 2016
Reported by FDA
November 9, 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.