Zydus Pharmaceuticals Inc recalls
25 recalls filed under Zydus Pharmaceuticals Inc. The most recent was published August 12, 2026.
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Class II · 2 months ago
Zydus Pharmaceuticals Inc Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle recall: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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Class II · 5 months ago
Zydus Pharmaceuticals Inc Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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Class II · 5 months ago
Zydus Pharmaceuticals Inc Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle recall: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
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Class II · 7 months ago
Zydus Pharmaceuticals Inc Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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Class II · 9 months ago
Zydus Pharmaceuticals Inc Icosapent Ethyl capsules, 1 gram, 120-count bottles recall: Subpotent Drug: Due to oxidation caused by leakage of the contents
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
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Class III · 10 months ago
Zydus Pharmaceuticals Inc traZodone Hydrochloride Tablets, USP, 100mg, 1,000 Tablets recall: Failed Tablet/Capsule Specifications: Product complaint received that some
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
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Class II · 11 months ago
Zydus Pharmaceuticals Inc Bromocriptine Mesylate Capsules, USP, 5 mg recall: Failed Impurities/Degradation Specifications: Out of Specification (OOS)
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 75 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 50 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 25 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 1 mg, 30-count bottle recall: Failed impurity/degradation specifications:Out of Specification result
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 0.5 mg, 30-count bottle recall: Failed impurity/degradation specifications:Out of Specification result
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 0.5 mg, 30 Tablets recall: Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 1 mg, 30 Tablets recall: Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 10 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Succinylcholine Chloride Injection, USP 200 mg/10 mL recall: Failed Impurities/Degradation Specifications: Out-of-Specification test
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 50 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 25 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 25 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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Class II · 1+ years ago
Zydus Pharmaceuticals Inc Chlorpromazine Hydrochloride Tablets, USP, 10 mg recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
About this page
Zydus Pharmaceuticals Inc appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.