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Zydus Pharmaceuticals (USA) Inc FDA Recalls
50 recalls on file across drugs, 2 of them Class I and 35 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Class IIAug 5, 2026CGMP: Due to Out of Specification (OOS) result for N-Nitroso |
| Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, Class IIApr 29, 2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromyci |
| Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, Class IIApr 29, 2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromyci |
| Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., IndiaClass IIMar 9, 2026Failed Tablet/Capsule specifications: Red dots inside capsul |
| Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, DistClass IIDec 30, 2025Subpotent Drug: Due to oxidation caused by leakage of the co |
| traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, DiClass IIIDec 19, 2025Failed Tablet/Capsule Specifications: Product complaint rece |
| Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., AClass IIOct 23, 2025Failed Impurities/Degradation Specifications: Out of Specifi |
| clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottleClass IIOct 22, 2025cGMP deviations: an observed Out of Specification of Nitrosa |
| clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottleClass IIOct 22, 2025cGMP deviations: an observed Out of Specification of Nitrosa |
| clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottleClass IIOct 22, 2025cGMP deviations: an observed Out of Specification of Nitrosa |
| Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistClass IISep 24, 2025Failed impurity/degradation specifications:Out of Specificat |
| Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DiClass IISep 24, 2025Failed impurity/degradation specifications:Out of Specificat |
| Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistributClass IISep 4, 2025Failed Impurity/Degradation Specifications |
| Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistribClass IISep 4, 2025Failed Impurity/Degradation Specifications |
| Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., BClass IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., BClass IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., BClass IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., BClass IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., BClass IISep 3, 2025CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromaz |
| Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, ManufactureClass IIAug 27, 2025Failed Impurities/Degradation Specifications: Out-of-Specifi |
| Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza,Class IIMay 30, 2025Failed Tablet/Capsule specifications; a product complaint wa |
| Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, ManClass IIMay 13, 2025Failed Impurities/Degradation Specifications: Out-of-Specifi |
| Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, ManClass IIMay 13, 2025Failed Impurities/Degradation Specifications: Out-of-Specifi |
| chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd.,Class IIApr 3, 2025CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromaz |
| Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: ZyduClass IIMar 21, 2025Presence of Foreign Substance: Product complaint received fo |
| Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL SingClass IIFeb 13, 2025Failed Impurities/Degradation Specifications |
| Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL SingClass IIFeb 13, 2025Failed Impurities/Degradation Specifications |
| Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: ZyduClass IIINov 14, 2024Labeling: Not Elsewhere Classified - Wrong NDC number |
| Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial Class IIIJul 2, 2024Cross contamination with other products. |
| Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 3Class IIIJul 2, 2024Cross contamination with other products |
| Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, ManufacturClass IIIJul 2, 2024Cross contamination with other products. |
| Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., VadodarClass IIIJul 2, 2024Cross contamination with other products |
| Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, MemphiClass IIJun 27, 2024Presence of particulate matter: glass |
| Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and Class IIJun 21, 2024Failed Dissolution Specifications: Out-of-specification resu |
| Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, AhmedClass IIIMay 16, 2024Failed Impurities/Degradation Specifications. |
| Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, AhmeClass IIIMay 16, 2024Failed Impurities/Degradation Specifications. |
| Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare LClass IIOct 19, 2023Failed Dissolution Specifications-out-of-specification (OOS) |
| Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare LtClass IIOct 19, 2023Failed Dissolution Specifications-out-of-specification (OOS) |
| Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare LClass IIOct 19, 2023Failed Dissolution Specifications-out-of-specification (OOS) |
| Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-Class IISep 21, 2023Failed Dissolution Specifications |
| Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 167Class IIIFeb 24, 2023Failed Impurities/Degradation Specifications: An out-of-spec |
| Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, ManufaClass IIJul 15, 2022Failed Impurities/Degradation Specifications |
| Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, DistributedClass IIAug 13, 2021Presence of Foreign Tablets/Capsules; report of two Paroxeti |
| Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIClass IFeb 18, 2021Crystallization: customer complaints for crystallization in |
| Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRClass IFeb 18, 2021Crystallization: customer complaints for crystallization in |