Public Health Trace

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

Drug Recall Terminated Historical recordClass III

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

by Purdue Pharma L.P.

Reason: Failed dissolution specifications
Recall initiated: July 13, 2015
Reported by FDA: July 29, 2015
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Captopril Tablets, USP, 100 mg Tablets, 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: 64679-0905-01.

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

Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), 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

Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), 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, 25 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: 64679-0945-01.

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

Zonisamide Capsules, 50 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: 64679-0946-01.

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

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), 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, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), 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, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), 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, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), 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

Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.

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

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

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, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

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, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), 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

Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.

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, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), 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, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), 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, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), 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

Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), 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

Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), 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 →

Data last updated: September 28, 2026 ET

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.