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Zydus Pharmaceuticals Usa Inc Recalls

92 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Zydus Pharmaceuticals Usa Inc.

92Total Recalls
4Critical
4.4MUnits Affected
Mar 9, 2026Most Recent
All Recalls

Every Zydus Pharmaceuticals Usa Inc Recall

Sorted by most recent. Click any recall for full details.

92 recalls
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by:...
Oral Drugs·60,541 affected·Mar 9, 2026
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus...
Oral Drugs·22,896 affected·Dec 30, 2025
RecallFDA
Zydus Pharmaceuticals (usa) Inc
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zyd...
Oral Drugs·2,136 affected·Dec 19, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. ...
Oral Drugs·36,624 affected·Oct 23, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-...
Oral Drugs·0 affected·Oct 22, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-...
Oral Drugs·0 affected·Oct 22, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-...
Oral Drugs·0 affected·Oct 22, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zyd...
Oral Drugs·912 affected·Sep 24, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus...
Oral Drugs·600 affected·Sep 24, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Phar...
Oral Drugs·4,440 affected·Sep 4, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Ph...
Oral Drugs·4,344 affected·Sep 4, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dist...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dist...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Man...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manu...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dis...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Man...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manu...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dis...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Dis...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manu...
Oral Drugs·0 affected·Sep 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesc...
Injectable Drugs·270,125 affected·Aug 27, 2025
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distribut...
Oral Drugs·11,616 affected·May 30, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·22,152 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·30,674 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Di...
Oral Drugs·3,144 affected·Apr 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals...
Oral Drugs·13,128 affected·Mar 21, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·1,893 affected·Feb 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·36,978 affected·Feb 13, 2025
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Lt...
Oral Drugs·4,404 affected·Nov 14, 2024
Medium RiskFDA
Zydus Pharmaceuticals (usa) Inc
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1...
Injectable Drugs·170,755 affected·Jul 2, 2024
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Life...
Injectable Drugs·8,020 affected·Jul 2, 2024
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distrib...
Injectable Drugs·12,720 affected·Jul 2, 2024
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufacture...
Injectable Drugs·0 affected·Jul 2, 2024
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd...
Injectable Drugs·432,250 affected·Jun 27, 2024
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bott...
Oral Drugs·13,128 affected·Jun 21, 2024
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Dist...
Drugs·13,440 affected·May 16, 2024
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Dis...
Drugs·21,360 affected·May 16, 2024
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. ...
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India....
Oral Drugs·0 affected·Oct 19, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, ...
Oral Drugs·7,248 affected·Sep 21, 2023
RecallFDA
Zydus Pharmaceuticals (usa) Inc
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manuf...
Oral Drugs·21,936 affected·Feb 24, 2023
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila...
Injectable Drugs·1,116 affected·Jul 15, 2022
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharma...
Oral Drugs·2,880 affected·Aug 13, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packa...
Injectable Drugs·816 affected·Feb 18, 2021
CriticalFDA
Zydus Pharmaceuticals (usa) Inc
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packag...
Injectable Drugs·1,638 affected·Feb 18, 2021
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: ...
Oral Drugs·15,144 affected·Dec 3, 2020