Zydus Pharmaceuticals Usa recalls
Zydus Pharmaceuticals Usa appears in 96 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 96 |
|---|---|
| Published | 2012-08-08 to 2026-10-21 |
| By agency | FDA Drug (96) |
| By classification | Class II (78), Class III (15), Class I (3) |
| By status | terminated (53), ongoing (36), completed (7) |
| Distribution named in notices | AZ, IL, LA, MS, OH, PA, PR, TN, US |
Recalls
- Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 39151…
FDA Drug · Class II · 2026-10-21 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications. - Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, D…
FDA Drug · Class II · 2026-08-12 · Zydus Pharmaceuticals Usa
Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. - Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit - Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit - Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa
Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. - Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-01-28 · Zydus Pharmaceuticals Usa
Reason: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules - traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus…
FDA Drug · Class III · 2026-01-07 · Zydus Pharmaceuticals Usa
Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. - Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only
FDA Drug · Class II · 2025-11-26 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. - clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02…
FDA Drug · Class II · 2025-11-12 · Zydus Pharmaceuticals Usa
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. - clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02…
FDA Drug · Class II · 2025-11-12 · Zydus Pharmaceuticals Usa
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. - clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02…
FDA Drug · Class II · 2025-11-12 · Zydus Pharmaceuticals Usa
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. - Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus…
FDA Drug · Class II · 2025-10-08 · Zydus Pharmaceuticals Usa
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity - Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus P…
FDA Drug · Class II · 2025-10-08 · Zydus Pharmaceuticals Usa
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity - Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharma…
FDA Drug · Class II · 2025-09-24 · Zydus Pharmaceuticals Usa
Reason: Failed Impurity/Degradation Specifications - Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Phar…
FDA Drug · Class II · 2025-09-24 · Zydus Pharmaceuticals Usa
Reason: Failed Impurity/Degradation Specifications - Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifescie…
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. - Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India
FDA Drug · Class II · 2025-09-17 · Zydus Pharmaceuticals Usa
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit - Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed…
FDA Drug · Class II · 2025-06-18 · Zydus Pharmaceuticals Usa
Reason: 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. - Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus…
FDA Drug · Class II · 2025-05-28 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. - Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus…
FDA Drug · Class II · 2025-05-28 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. - chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Dist…
FDA Drug · Class II · 2025-04-16 · Zydus Pharmaceuticals Usa
Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit - Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (…
FDA Drug · Class II · 2025-04-16 · Zydus Pharmaceuticals Usa
Reason: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. - Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1
FDA Drug · Class II · 2025-03-12 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications - Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1
FDA Drug · Class II · 2025-03-12 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications - Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd
FDA Drug · Class III · 2024-12-11 · Zydus Pharmaceuticals Usa
Reason: Labeling: Not Elsewhere Classified - Wrong NDC number - Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottle…
FDA Drug · Class II · 2024-07-31 · Zydus Pharmaceuticals Usa
Reason: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. - Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd.…
FDA Drug · Class II · 2024-07-24 · Zydus Pharmaceuticals Usa
Reason: Presence of particulate matter: glass - Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1
FDA Drug · Class III · 2024-07-17 · Zydus Pharmaceuticals Usa
Reason: Cross 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, Manufactured by: Zydus Lifesc…
FDA Drug · Class III · 2024-07-17 · Zydus Pharmaceuticals Usa
Reason: Cross contamination with other products. - Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured…
FDA Drug · Class III · 2024-07-17 · Zydus Pharmaceuticals Usa
Reason: Cross contamination with other products - Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distribut…
FDA Drug · Class III · 2024-07-17 · Zydus Pharmaceuticals Usa
Reason: Cross contamination with other products - Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distr…
FDA Drug · Class III · 2024-06-12 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications. - Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distri…
FDA Drug · Class III · 2024-06-12 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications. - Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India
FDA Drug · Class II · 2023-11-15 · Zydus Pharmaceuticals Usa
Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India
FDA Drug · Class II · 2023-11-15 · Zydus Pharmaceuticals Usa
Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India
FDA Drug · Class II · 2023-11-15 · Zydus Pharmaceuticals Usa
Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx…
FDA Drug · Class II · 2023-10-11 · Zydus Pharmaceuticals Usa
Reason: Failed 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 16714-0039-02, Manufac…
FDA Drug · Class III · 2023-03-22 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine. - Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila H…
FDA Drug · Class II · 2022-08-24 · Zydus Pharmaceuticals Usa
Reason: Failed Impurities/Degradation Specifications - Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmace…
FDA Drug · Class II · 2021-08-25 · Zydus Pharmaceuticals Usa
Reason: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle - Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged…
FDA Drug · Class I · 2021-04-07 · Zydus Pharmaceuticals Usa
Reason: Crystallization: customer complaints for crystallization in finished product.