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Zydus Pharmaceuticals (USA) Recalls
95 recalls on record · August 8, 2012 to August 12, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Sing
Hazard: Failed Impurities/Degradation Specifications
March 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Sing
Hazard: Failed Impurities/Degradation Specifications
December 11, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydu
Hazard: Labeling: Not Elsewhere Classified - Wrong NDC number
July 31, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and
Hazard: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
July 24, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphi
Hazard: Presence of particulate matter: glass
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 3
Hazard: Cross contamination with other products
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodar
Hazard: Cross contamination with other products
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactur
Hazard: Cross contamination with other products.
July 17, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial
Hazard: Cross contamination with other products.
June 12, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmed
Hazard: Failed Impurities/Degradation Specifications.
June 12, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahme
Hazard: Failed Impurities/Degradation Specifications.
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare L
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare L
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
November 15, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Lt
Hazard: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
October 11, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-
Hazard: Failed Dissolution Specifications
March 22, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 167
Hazard: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
August 24, 2022DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufa
Hazard: Failed Impurities/Degradation Specifications
August 25, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed
Hazard: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
April 7, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRI
Hazard: Crystallization: customer complaints for crystallization in finished product.
April 7, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PR
Hazard: Crystallization: customer complaints for crystallization in finished product.
December 23, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only
Hazard: Failed Dissolution Specifications
December 23, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only,
Hazard: Failed Dissolution Specifications
November 11, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufact
Hazard: Failed Dissolution Specification
November 11, 2020DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufact
Hazard: Failed Dissolution Specification
February 19, 2020DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited,
Hazard: cGMP Deviations
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, I
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Phar
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.