--- title: "Zydus Pharmaceuticals (USA) Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Zydus Pharmaceuticals (USA) Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/zydus-pharmaceuticals-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Zydus Pharmaceuticals (USA) Inc recall records **35** reported ongoing 47 records in this archive. Latest source date Aug 5, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 5, 2026 FDA drug enforcement ### [Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (...](https://isitonrecall.com/recall/fda-drug-d-0745-2026-mirabegron-extended-release-tablets-25-mg-30-count-bottle-rx-only-manufactured-by-zydus-lifesciences/) CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Life...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0745-2026%22) Apr 29, 2026 FDA drug enforcement ### [Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., ...](https://isitonrecall.com/recall/fda-drug-d-0544-2026-erythromycin-tablets-usp-250-mg-30-tablets-per-bottle-rx-only-manufactured-by-zydus-lifesciences-ltd/) CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesci...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0544-2026%22) Apr 29, 2026 FDA drug enforcement ### [Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., ...](https://isitonrecall.com/recall/fda-drug-d-0545-2026-erythromycin-tablets-usp-500-mg-30-tablets-per-bottle-rx-only-manufactured-by-zydus-lifesciences-ltd/) CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesci...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0545-2026%22) Mar 9, 2026 FDA drug enforcement ### [Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Penni...](https://isitonrecall.com/recall/fda-drug-d-0400-2026-icosapent-ethyl-capsules-1-gram-120-capsules-per-bottle-rx-only-manufactured-by-softgel-healthcare-p/) Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Heal...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0400-2026%22) Dec 30, 2025 FDA drug enforcement ### [Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,...](https://isitonrecall.com/recall/fda-drug-d-0295-2026-icosapent-ethyl-capsules-1-gram-120-count-bottles-rx-only-manufactured-by-softgel-healthcare-pvt-ltd/) Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules Class II Reported ongoing Distribution: US Nationwide. [Official source for Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0295-2026%22) Dec 19, 2025 FDA drug enforcement ### [traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Penningto...](https://isitonrecall.com/recall/fda-drug-d-0247-2026-trazodone-hydrochloride-tablets-usp-100mg-1-000-tablets-rx-only-manufactured-by-zydus-lifesciences-l/) Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. Class III Reported ongoing Distribution: Nationwide in the USA [Official source for traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifes...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0247-2026%22) Oct 23, 2025 FDA drug enforcement ### [Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, P...](https://isitonrecall.com/recall/fda-drug-d-0159-2026-bromocriptine-mesylate-capsules-usp-5-mg-30-capsules-per-bottle-rx-only-manufactured-by-zydus-lifesc/) Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0159-2026%22) Oct 22, 2025 FDA drug enforcement ### [clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849...](https://isitonrecall.com/recall/fda-drug-d-0152-2026-clomipramine-hydrochloride-capsules-usp-25-mg-packaged-in-a-30-count-bottles-ndc-16714-849-01-b-90-c/) cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0152-2026%22) Oct 22, 2025 FDA drug enforcement ### [clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850...](https://isitonrecall.com/recall/fda-drug-d-0153-2026-clomipramine-hydrochloride-capsules-usp-50-mg-packaged-in-a-30-count-bottles-ndc-16714-850-01-b-90-c/) cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0153-2026%22) Oct 22, 2025 FDA drug enforcement ### [clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 R...](https://isitonrecall.com/recall/fda-drug-d-0154-2026-clomipramine-hydrochloride-capsules-usp-75-mg-packaged-in-a-30-count-bottles-ndc-16714-851-01-b-90-c/) cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0154-2026%22) Sep 24, 2025 FDA drug enforcement ### [Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Penningto...](https://isitonrecall.com/recall/fda-drug-d-0001-2026-entecavir-tablets-usp-0-5-mg-30-count-bottle-rx-only-manufactured-by-zydus-lifesciences-ltd-ahmedaba/) Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0001-2026%22) Sep 24, 2025 FDA drug enforcement ### [Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,...](https://isitonrecall.com/recall/fda-drug-d-0002-2026-entecavir-tablets-usp-1-mg-30-count-bottle-rx-only-manufactured-by-zydus-lifesciences-ltd-ahmedabad/) Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd.,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0002-2026%22) Sep 4, 2025 FDA drug enforcement ### [Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ...](https://isitonrecall.com/recall/fda-drug-d-0656-2025-entecavir-tablets-usp-0-5-mg-30-tablets-rx-only-manufactured-by-zydus-lifesciences-ltd-ahmedabad-ind/) Failed Impurity/Degradation Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0656-2025%22) Sep 4, 2025 FDA drug enforcement ### [Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0...](https://isitonrecall.com/recall/fda-drug-d-0657-2025-entecavir-tablets-usp-1-mg-30-tablets-rx-only-manufactured-by-zydus-lifesciences-ltd-ahmedabad-india/) Failed Impurity/Degradation Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahme...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0657-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) ...](https://isitonrecall.com/recall/fda-drug-d-0630-2025-chlorpromazine-hydrochloride-tablets-usp-10-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0630-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, ...](https://isitonrecall.com/recall/fda-drug-d-0631-2025-chlorpromazine-hydrochloride-tablets-usp-10-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0631-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) ...](https://isitonrecall.com/recall/fda-drug-d-0632-2025-chlorpromazine-hydrochloride-tablets-usp-25-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0632-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, ...](https://isitonrecall.com/recall/fda-drug-d-0633-2025-chlorpromazine-hydrochloride-tablets-usp-25-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0633-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) ...](https://isitonrecall.com/recall/fda-drug-d-0634-2025-chlorpromazine-hydrochloride-tablets-usp-50-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0634-2025%22) Sep 3, 2025 FDA drug enforcement ### [Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, ...](https://isitonrecall.com/recall/fda-drug-d-0635-2025-chlorpromazine-hydrochloride-tablets-usp-50-mg-100-count-bottle-rx-only-manufactured-by-zydus-lifesc/) CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zyd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0635-2025%22) ## Reasons in these listed records - CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. - CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit - Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. - Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules These examples come from this result page and are not a ranking of every recall reason. ## Checking Zydus Pharmaceuticals (USA) Inc ### Is there a recall on zydus pharmaceuticals (usa) inc right now? This archive contains 47 records, including 35 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Zydus Pharmaceuticals (USA) Inc](https://isitonrecall.com/check/?q=Zydus%20Pharmaceuticals%20%28USA%29%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)