Zydus Pharmaceuticals (USA) Inc

Complete recall history across all FDA and CPSC categories — 51 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 (51)

FDA drug safety enforcement actions by Zydus Pharmaceuticals (USA) Inc. Showing most recent 50.

Date Product Reason Class
Mar 9, 2026 Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... Failed Tablet/Capsule specifications: Red dots inside capsule and melted caps... Class II
Dec 30, 2025 Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by... Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosap... Class II
Dec 19, 2025 traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... Failed Tablet/Capsule Specifications: Product complaint received that some ta... Class III
Oct 23, 2025 Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. ... Failed Impurities/Degradation Specifications: Out of Specification (OOS) resu... Class II
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substan... Class II
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substan... Class II
Oct 22, 2025 clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substan... Class II
Sep 24, 2025 Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydu... Failed impurity/degradation specifications:Out of Specification result for an... Class II
Sep 24, 2025 Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zy... Failed impurity/degradation specifications:Out of Specification result for an... Class II
Sep 4, 2025 Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus L... Failed Impurity/Degradation Specifications Class II
Sep 4, 2025 Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lif... Failed Impurity/Degradation Specifications Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only,... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Sep 3, 2025 Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, ... CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the rec... Class II
Aug 27, 2025 Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 ... Failed Impurities/Degradation Specifications: Out-of-Specification test resul... Class II
May 30, 2025 Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactur... Failed Tablet/Capsule specifications; a product complaint was reported for bu... Class II
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... Failed Impurities/Degradation Specifications: Out-of-Specification test resul... Class II
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... Failed Impurities/Degradation Specifications: Out-of-Specification test resul... Class II
Apr 3, 2025 chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity abov... Class II
Mar 21, 2025 Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... Presence of Foreign Substance: Product complaint received for the presence of... Class II
Feb 13, 2025 Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... Failed Impurities/Degradation Specifications Class II
Feb 13, 2025 Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... Failed Impurities/Degradation Specifications Class II
Nov 14, 2024 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... Labeling: Not Elsewhere Classified - Wrong NDC number Class III
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III
Jul 2, 2024 Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... Cross contamination with other products Class III
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... Cross contamination with other products. Class III
Jul 2, 2024 Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... Cross contamination with other products. Class III
Jun 27, 2024 Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,... Presence of particulate matter: glass Class II
Jun 21, 2024 Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in ... Failed Dissolution Specifications: Out-of-specification results observed for ... Class II
May 16, 2024 Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manuf... Failed Impurities/Degradation Specifications. Class III
May 16, 2024 Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufa... Failed Impurities/Degradation Specifications. Class III
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... Failed Dissolution Specifications-out-of-specification (OOS) test results obs... Class II
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... Failed Dissolution Specifications-out-of-specification (OOS) test results obs... Class II
Oct 19, 2023 Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... Failed Dissolution Specifications-out-of-specification (OOS) test results obs... Class II
Sep 21, 2023 Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... Failed Dissolution Specifications Class II
Feb 24, 2023 Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... Failed Impurities/Degradation Specifications: An out-of-specification (OOS) r... Class III
Jul 15, 2022 Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... Failed Impurities/Degradation Specifications Class II
Aug 13, 2021 Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were f... Class II
Feb 18, 2021 Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For In... Crystallization: customer complaints for crystallization in finished product. Class I
Feb 18, 2021 Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For I... Crystallization: customer complaints for crystallization in finished product. Class I
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet... Failed Dissolution Specifications Class II
Dec 3, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets... Failed Dissolution Specifications Class II
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c... Failed Dissolution Specification Class II

View all 51 drug recalls →

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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