Wockhardt Usa Inc.

Complete recall history across all FDA and CPSC categories — 45 total recalls

Wockhardt Usa Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (45)

FDA drug safety enforcement actions by Wockhardt Usa Inc.

Date Product Reason Class
Aug 22, 2017 Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture... Failed Impurities/Degradation Specifications: 5mg strength being recalled for... Class III
Jul 29, 2015 Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... CGMP Deviations: An FDA inspection identified inadequate investigations of pa... Class II
Jul 29, 2015 Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... CGMP Deviations: An FDA inspection identified inadequate investigations of pa... Class II
Apr 22, 2015 Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,00... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (ND... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only.... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx onl... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles,... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Co... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 6... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx o... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging O... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Onl... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bott... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manuf... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II
Mar 12, 2015 Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-0... Failed Tablet/Capsule Specifications: out of specification for thickness. Class II
Jul 24, 2014 Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-c... Failed Dissolution Specifications: Dissolution failures found during testing ... Class II
Jul 14, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... Failed Impurities/Degradation Products: Out of specification levels of the im... Class III
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at ... Class III
Apr 10, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle,... Failed Dissolution Specifications: Failure of dissolution test observed at th... Class II
Apr 1, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, R... Failed Dissolution Specifications: failure of dissolution test observed at ni... Class II
Nov 27, 2013 Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle,... Failed Dissolution Specifications; 12 month acid dissolution test results wer... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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