Zydus Pharmaceuticals USA Inc

Complete recall history across all FDA and CPSC categories — 41 total recalls

Zydus Pharmaceuticals 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 (41)

FDA drug safety enforcement actions by Zydus Pharmaceuticals USA Inc

Date Product Reason Class
Jan 31, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... cGMP Deviations Class II
May 6, 2019 Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Ma... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufa... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: C... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
May 6, 2019 MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by:... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning... Class II
Apr 25, 2019 Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by:... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Ta... Class II
Apr 25, 2019 Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: C... Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Ta... Class II
Apr 22, 2019 Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by... Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, ... Class III
Nov 20, 2017 Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count... Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottl... Class II
Aug 18, 2017 Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cad... Presence of Foreign tablets/capsules: risperidone Tablets were found in bottl... Class II
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ... Failed Dissolution Specifications Class II
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ... Failed Dissolution Specifications Class II
May 10, 2017 Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ... Failed Dissolution Specifications Class II
Mar 15, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... Failed Dissolution Specifications; 9 month long term stability Class II
Mar 6, 2017 ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023... Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of ate... Class II
Nov 2, 2016 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3... Failed Dissolution Specifications; 6 month time point Class III
Aug 3, 2016 BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, ... Failed Dissolution Specifications: Product did not meet dissolution specifica... Class III
Jul 19, 2016 Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68... Failed Dissolution Specifications: out of specification dissolution results i... Class II
Jul 19, 2016 Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 6... Failed Dissolution Specifications: out of specification dissolution results i... Class II
May 9, 2016 Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufac... Failed impurities/degradation specifications: Out of specification results no... Class II
Jan 14, 2016 risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manu... Failed Impurities/Degradation Specifications: Out of specification for a know... Class III
Dec 23, 2014 Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthca... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II
Nov 26, 2014 Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured b... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II
Oct 1, 2014 Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manuf... Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets... Class III
Sep 24, 2014 BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured... Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benz... Class III
Sep 15, 2014 TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila... Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled ... Class II
Aug 5, 2014 ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufacture... Superpotent Drug: A complaint was reported by a pharmacist who stated several... Class II
May 8, 2014 PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. ... Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into pro... Class II
May 13, 2013 Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufa... Failed Tablet/Capsule Specifications: A product complaint was received from a... Class I
Mar 5, 2013 Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx o... Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive am... Class II
Mar 14, 2012 Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets pe... Presence of Foreign Substance(s): A product complaint was received from a pha... 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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