Wockhardt Usa Recalls
45 recalls on record · February 5, 2014 to November 1, 2017 · Drugs
Recalls by year
14
15
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC:
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, Indi
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limit
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 10
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumb
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (N
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
July 29, 2015DrugsFDA
Wockhardt Usa Inc. recalls Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,
Hazard: CGMP Deviations: Firm did not adequately investigate customer complaints.
May 13, 2015DrugsFDA
Wockhardt Usa Inc. recalls Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02,
Hazard: Failed Tablet/Capsule Specifications: out of specification for thickness.
December 24, 2014DrugsFDA
Wockhardt Usa Inc. recalls Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 40
Hazard: Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
August 27, 2014DrugsFDA
Wockhardt Usa Inc. recalls Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-coun
Hazard: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
August 13, 2014DrugsFDA
Wockhardt Usa Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited,
Hazard: Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
June 4, 2014DrugsFDA
Wockhardt Usa Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limite
Hazard: Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
May 14, 2014DrugsFDA
Wockhardt Usa Inc. recalls Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited,
Hazard: Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
February 5, 2014DrugsFDA
Wockhardt Usa Inc. recalls Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limite
Hazard: Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.