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Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc Recalls

All product recalls associated with Zydus Pharmaceuticals (USA) Inc.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 161–180 of 25000 recalls

Clomipramine 50mg Capsules (Zydus) - Nitrosamine Risk (2025)

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 IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Holiday Rambler Invicta (Holiday Rambler) – Latch Defect (2026)

Fire/Burn Risk

REV Recreation Group (REV) is recalling certain 2024-2026 Holiday Rambler Invicta and Fleetwood Fortis recreational vehicles equipped with Lippert Paddle latches with part number 2021097882. The paddle latch may unintentionally lock, preventing operators from accessing the Liquid Propane (LP) compartment.

NHTSAOct 21, 2025Nationwide• HOLIDAY RAMBLER

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

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Potential for anesthesia leakage.

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

NIACIN Extended-Release Tablets (Golden State) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAOct 20, 2025Nationwide• Golden State Medical Supply Inc.

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

IntelePACS (Intelerad) – Software Communication Bug (2025)

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

FDAOct 17, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

Emdogain (Straumann) – Unintended Patient Use Risk (2025)

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

FDAOct 17, 2025Nationwide• Straumann USA LLC

MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (2025)

A potential issue with the seal integrity of header bag packaging.

FDAOct 17, 2025Nationwide• Mozarc Medical US LLC

Multichem ID-B (Techno-Path) – HBsAg Recovery Issue (2025)

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

FDAOct 17, 2025CA, CO, CT +14 more• TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland

EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

FDAOct 17, 2025AK, CA, IA +3 more• Olympus Corporation of the Americas

Alexis Fire Apparatus (Alexis Fire Equipment) – Door Latch Problem (2025)

Fire/Burn Risk

Alexis Fire Equipment Company (Alexis Fire) is recalling certain 2020-2025 Pumper, 2024 Rescue, and 2020-2024 Tanker fire trucks built on Spartan chassis. The actuator lever arm in the Spartan cab door latch may bind or become wedged, preventing the door from opening.

NHTSAOct 16, 2025Nationwide• ALEXIS FIRE EQUIPMENT

AOWOS Dressers - Tip-Over Risk (2025)

This recall involves AOWOS 12-drawer dressers. The recalled dressers were sold in black, brown, gray, oak, pink and white. They have a metal frame, wooden top, 12 collapsing fabric drawers of different sizes with handles, four side pockets and two hooks. The dressers measure about 39 inches by 12 inches by 44.5 inches, and weigh about 42 pounds. Model number 12DRW01, 12DRW02, 12DRW11, 12DRW13, 12DRW19, 12DRW20 or 12DRW27 is printed on the product packaging.

CPSCOct 16, 2025Nationwide• Shenzhen Shuanglong Home Furnishing Co., Ltd., of China

Prazosin Hydrochloride 2mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

VANTAGE GALAN 3T (Canon Medical) – Electrode Distance Compliance (2025)

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

FDAOct 16, 2025NV, OH• Canon Medical System, USA, INC.

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

FDAOct 16, 2025Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

EVIS EXERA III Duodenovideoscope (Olympus) – Reprocessing Update (2025)

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

FDAOct 14, 2025Nationwide• Olympus Corporation of the Americas

Beckman Coulter Bicarbonate Reagent (Beckman) – Result Interference (2025)

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

FDAOct 14, 2025Nationwide• Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland

Testosterone Triamcinolone Pellet (Farmakeio) – Metal Contamination (2025)

CGMP Deviations: Potential presence of metal particulate matter

Class IIModerate

FDAOct 14, 2025Nationwide• FARMAKEIO OUTSOURCING LLC