Wockhardt Usa recalls
Wockhardt Usa appears in 45 official U.S. recall notices indexed by RecallRadar, most recently on 2017-11-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 45 |
|---|---|
| Published | 2014-02-05 to 2017-11-01 |
| By agency | FDA Drug (45) |
| By classification | Class II (42), Class III (3) |
| By status | terminated (45) |
| Distribution named in notices | US |
Recalls
- Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangab…
FDA Drug · Class III · 2017-11-01 · Wockhardt Usa
Reason: Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound. - Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa
Reason: CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. - Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa
Reason: CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. - Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-71…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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: 6467…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bott…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bott…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-0…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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),…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC:…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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), R…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (ND…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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)…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bot…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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)…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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)…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (N…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - 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)…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints. - Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Woc…
FDA Drug · Class II · 2015-05-13 · Wockhardt Usa
Reason: Failed Tablet/Capsule Specifications: out of specification for thickness. - Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-…
FDA Drug · Class III · 2014-12-24 · Wockhardt Usa
Reason: Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point. - Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679…
FDA Drug · Class II · 2014-08-27 · Wockhardt Usa
Reason: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. - buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class III · 2014-08-13 · Wockhardt Usa
Reason: Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. - Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only
FDA Drug · Class II · 2014-06-04 · Wockhardt Usa
Reason: Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. - Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2014-05-14 · Wockhardt Usa
Reason: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. - Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only
FDA Drug · Class II · 2014-02-05 · Wockhardt Usa
Reason: Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.