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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 10,901–10,920 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)

by Qinhuangdao Zizhu Pharmaceutical, Co.

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
March 24, 2017
Reported by FDA
April 19, 2017
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ

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Drug Recall Terminated Historical recordClass II

Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)

by Qinhuangdao Zizhu Pharmaceutical, Co.

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
March 24, 2017
Reported by FDA
April 19, 2017
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ

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Drug Recall Terminated Historical recordClass II

Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06

by Qinhuangdao Zizhu Pharmaceutical, Co.

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
March 24, 2017
Reported by FDA
April 19, 2017
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ

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Drug Recall Terminated Historical recordClass II

Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China

by Qinhuangdao Zizhu Pharmaceutical, Co.

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
March 24, 2017
Reported by FDA
April 19, 2017
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ

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Drug Recall Terminated Historical recordClass II

Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)

by Qinhuangdao Zizhu Pharmaceutical, Co.

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
March 24, 2017
Reported by FDA
April 19, 2017
Distribution
Product distributed to NY, TX, SC, CO, MN and NJ

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Drug Recall Terminated Historical recordClass III

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

by Novel Laboratories, Inc.

Reason
Chemical Contamination
Recall initiated
February 22, 2017
Reported by FDA
April 19, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99

by Citron Pharma Llc

Reason
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Recall initiated
February 24, 2017
Reported by FDA
April 19, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19

by West-Ward Columbus, Inc.

Reason
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Recall initiated
April 4, 2017
Reported by FDA
April 19, 2017
Distribution
The recalled product was distributed to the following state: OH. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. There are no government accounts for this recall.

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Drug Recall Terminated Historical recordClass III

Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; Impurity A
Recall initiated
December 7, 2015
Reported by FDA
April 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60

by Dr. Reddy's Laboratories, Inc.

Reason
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Recall initiated
March 6, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. nationwide

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Drug Recall Terminated Historical recordClass II

Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.

by Genentech Inc.

Reason
Superpotent Drug: An oversized tablet was found in a bottle.
Recall initiated
March 13, 2017
Reported by FDA
April 12, 2017
Distribution
NJ and IL

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Drug Recall Terminated Historical recordClass III

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

by Fresenius Kabi USA, LLC

Reason
Subpotent Drug
Recall initiated
March 16, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide within the US

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Drug Recall Terminated Historical recordClass I

XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768

by Organic Herbal Supply

Reason
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
Recall initiated
February 16, 2017
Reported by FDA
April 12, 2017
Distribution
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com

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Drug Recall Terminated Historical recordClass I

Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass I

Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass I

Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40

by SCA Pharmaceuticals

Reason
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Recall initiated
February 3, 2017
Reported by FDA
April 12, 2017
Distribution
U.S. 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.