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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.
August 12, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,
Hazard: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
May 27, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,
Hazard: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
May 27, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,
Hazard: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
March 18, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India
Hazard: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
January 28, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dist
Hazard: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
January 7, 2026DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Di
Hazard: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
November 26, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., A
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
November 12, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottle
Hazard: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
October 8, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Dist
Hazard: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
October 8, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Di
Hazard: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
September 24, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribut
Hazard: Failed Impurity/Degradation Specifications
September 24, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distrib
Hazard: Failed Impurity/Degradation Specifications
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufacture
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
June 18, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza,
Hazard: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
May 28, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Man
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
May 28, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Man
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
April 16, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd.,
Hazard: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
April 16, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydu
Hazard: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.