Zydus Pharmaceuticals (USA) Inc: FDA recalls

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Share of the events of the firm in Class I

4%

Share of all events on the register in Class I

18%

Events with the status Ongoing

17

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

• FDA enforcement reportsThe FDA search of the weekly enforcement reports.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA: report a problemThe FDA page that shows where a report about a product goes.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Which classes do the FDA recalls of Zydus Pharmaceuticals (USA) Inc have?

Class II: 40 events. Class III: 12 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.

What is the newest FDA recall of Zydus Pharmaceuticals (USA) Inc?

FDA event 99563, which the firm started on 5 Aug 2026. The first product in the record is: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

How many FDA recalls of Zydus Pharmaceuticals (USA) Inc have the status Ongoing?

17 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.