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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 13,681–13,700 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

by Wockhardt Usa Inc.

Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recall initiated
April 22, 2015
Reported by FDA
July 29, 2015
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Ongoing Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

by Hospira Inc.

Reason
Crystallization; identified as calcium salt of Ketorolac
Recall initiated
June 30, 2015
Reported by FDA
July 22, 2015
Distribution
Nationwide, Puerto Rico, Guam, Canada and Singapore

View recall →

Drug Recall Ongoing Historical recordClass II

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

by Hospira Inc.

Reason
Crystallization; identified as calcium salt of Ketorolac
Recall initiated
June 30, 2015
Reported by FDA
July 22, 2015
Distribution
Nationwide, Puerto Rico, Guam, Canada and Singapore

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68

by Hospira Inc.

Reason
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Recall initiated
July 2, 2015
Reported by FDA
July 22, 2015
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass III

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Recall initiated
June 29, 2015
Reported by FDA
July 22, 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.