DrugAug 12, 2026
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle recall — FDA D-0745-2026
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
Recall history in this database
Classification mix: Class II: 29, Class III: 2.
DrugMay 27, 2026
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle recall — FDA D-0545-2026
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugMay 27, 2026
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle recall — FDA D-0544-2026
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugMar 18, 2026
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle recall — FDA D-0400-2026
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugJan 28, 2026
Zydus Pharmaceuticals (USA) Icosapent Ethyl capsules, 1 gram, 120-count bottles recall — FDA D-0295-2026
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugJan 7, 2026
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets recall — FDA D-0247-2026
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class IIIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugNov 26, 2025
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle recall — FDA D-0159-2026
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugNov 12, 2025
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recall — FDA D-0152-2026
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 IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugNov 12, 2025
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recall — FDA D-0153-2026
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 IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugNov 12, 2025
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recall — FDA D-0154-2026
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 IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugOct 8, 2025
Entecavir Tablets, USP, 0.5 mg, 30-count bottle recall — FDA D-0001-2026
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugOct 8, 2025
Entecavir Tablets, USP, 1 mg, 30-count bottle recall — FDA D-0002-2026
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle recall — FDA D-0634-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle recall — FDA D-0630-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle recall — FDA D-0637-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle recall — FDA D-0633-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle recall — FDA D-0632-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle recall — FDA D-0639-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle recall — FDA D-0635-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL) recall — FDA D-0623-2025
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle recall — FDA D-0636-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle recall — FDA D-0638-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugSep 17, 2025
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle recall — FDA D-0631-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugJun 18, 2025
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle recall — FDA D-0497-2025
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.
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
Understanding this recall history
This page summarizes recall records in which the official source identifies Zydus Pharmaceuticals (USA) Inc as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.