Zydus Pharmaceuticals (USA) Inc recalls

36 recalls on record · latest: April 29, 2026

Official U.S. recall history for Zydus Pharmaceuticals (USA) Inc, compiled from official government records.

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Erythromycin Tablets recalled over manufacturing violations

April 29, 2026 · Drug & medication recalls Moderate risk CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recomme…

Erythromycin Tablets recalled over manufacturing violations

April 29, 2026 · Drug & medication recalls Moderate risk CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recomme…

Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., Indi…

March 9, 2026 · Drug & medication recalls Moderate risk Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsul…

Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dis…

December 30, 2025 · Drug & medication recalls Moderate risk Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsu…

Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, D…

December 19, 2025 · Drug & medication recalls Failed Tablet/Capsule Specifications: Product complaint received that some tabl…

Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…

October 23, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: Out of Specification (OOS) result…

ClomiPRAMINE Hydrochloride recalled over manufacturing violations

October 22, 2025 · Drug & medication recalls Moderate risk cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance…

ClomiPRAMINE Hydrochloride recalled over manufacturing violations

October 22, 2025 · Drug & medication recalls Moderate risk cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance…

ClomiPRAMINE Hydrochloride recalled over manufacturing violations

October 22, 2025 · Drug & medication recalls Moderate risk cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance…

Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Dis…

September 24, 2025 · Drug & medication recalls Moderate risk Failed impurity/degradation specifications:Out of Specification result for an i…

Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, D…

September 24, 2025 · Drug & medication recalls Moderate risk Failed impurity/degradation specifications:Out of Specification result for an i…

Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distri…

September 4, 2025 · Drug & medication recalls Moderate risk Failed Impurity/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribu…

September 4, 2025 · Drug & medication recalls Moderate risk Failed Impurity/Degradation Specifications

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Chlorpromazine Hydrochloride Tablets recalled over manufacturing violations

September 3, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recom…

Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactur…

August 27, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: Out-of-Specification test results…

Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza…

May 30, 2025 · Drug & medication recalls Moderate risk Failed Tablet/Capsule specifications; a product complaint was reported for burn…

Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Ma…

May 13, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: Out-of-Specification test results…

Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Ma…

May 13, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: Out-of-Specification test results…

ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations

April 3, 2025 · Drug & medication recalls Moderate risk CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above…

Venlafaxine Tablets recalled over possible metal fragments

March 21, 2025 · Drug & medication recalls Moderate risk Presence of Foreign Substance: Product complaint received for the presence of f…

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…

February 13, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications

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…

February 13, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zyd…

November 14, 2024 · Drug & medication recalls Labeling: Not Elsewhere Classified - Wrong NDC number

Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN…

July 2, 2024 · Drug & medication recalls Cross contamination with other products

Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadoda…

July 2, 2024 · Drug & medication recalls Cross contamination with other products

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, Manufactu…

July 2, 2024 · Drug & medication recalls Cross contamination with other products.

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…

July 2, 2024 · Drug & medication recalls Cross contamination with other products.