Zydus Pharmaceuticals recalls
26 official recalls and safety alerts involving Zydus Pharmaceuticals since 2022-08, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Zydus Pharmaceuticals or the relevant agency.
- 2026-08-12
USZydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,…
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- 2026-05-27
- US
Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- 2026-03-18
- US
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India;…
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- 2026-01-28
- US
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed…
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- 2026-01-07
- US
Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,…
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- 2025-11-26
- US
Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- 2025-11-12
- US
Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- 2025-10-08
- US
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- 2025-09-24
- US
Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by:…
Failed Impurity/Degradation Specifications
- 2025-09-17
- US
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi,…
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- US
Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by…
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- 2025-06-18
- US
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy,…
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.
- 2025-05-28
- US
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only,…
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- 2025-04-16
- US
Zydus Pharmaceuticals (USA) Inc recalls chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi,…
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
FDA · DrugZydus Pharmaceuticals (USA) IncNationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA,…Official notice → - US
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus…
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
- 2025-03-12
- US
Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose…
Failed Impurities/Degradation Specifications
- 2024-12-11
- US
Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus…
Labeling: Not Elsewhere Classified - Wrong NDC number
- 2024-07-31
- US
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and…
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
- 2024-07-24
- US
- 2024-07-17
- US
- US
- 2024-06-12
- US
Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad,…
Failed Impurities/Degradation Specifications.
- 2023-11-15
- US
Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd,…
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- 2023-10-11
- US
- 2023-03-22
- US
Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…
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.
- 2022-08-24
- US
Zydus Pharmaceuticals (USA) Inc recalls Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured…
Failed Impurities/Degradation Specifications