Wockhardt Ltd.
FDA import alert and refusal historyMumbai, IndiaFEI 3004272092
As of October 26, 2026, Wockhardt Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between February 6, 2025 and October 21, 2025, most often for unapproved new drug (UNAPPROVED).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Mecobalamin (vitamin) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Wockhardt Ltd.
2 records, newest first. Each line links to the FDA page it came from.
2025
- Import refusalRefused, Mecobalamin (vitamin)UNAPPROVEDEntry AEK-7752142-3Source
- Import refusalRefused, Mecobalamin (vitamin)UNAPPROVEDEntry 799-5697900-0Source
Refusal charges, in plain English
- UNAPPROVED2 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
Questions about Wockhardt Ltd.
- Is Wockhardt Ltd. on an FDA import alert?
- No listing for Wockhardt Ltd. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.
- Has FDA refused shipments from Wockhardt Ltd.?
- Yes. FDA refused 2 shipment lines from Wockhardt Ltd. between February 6, 2025 and October 21, 2025. The most recent, on October 21, 2025, was mecobalamin (vitamin), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Wockhardt Ltd.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
- What is Wockhardt Ltd.'s FEI number?
- Wockhardt Ltd.'s FDA Establishment Identifier (FEI) is 3004272092.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.