Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility
Hikal Limited, an Indian pharmaceutical and API manufacturer, received a warning letter from the US FDA on August 20, 2025, regarding its Jigani, Bengaluru manufacturing facility635.
The warning followed a regulatory inspection conducted by the US FDA at the Jigani plant from February 3 to February 7, 2025356.
The FDA letter cites issues related to alleged metal contamination in active pharmaceutical ingredients (APIs) as well as other GMP (Good Manufacturing Practice) violations including inadequate cleaning procedures, product residues on equipment, and poor facility maintenance125.
Hikal received multiple complaints since 2020 about black, metallic particles found in its products after process modifications at the affected plant1. The company eventually acknowledged the particles were 'metallic in nature,' but claimed these were 'technically unavoidable' and beyond the detection limit of their metal detector system1.
Despite admitting some cleaning failures, Hikal disputed the risk of cross-contamination because of the dedicated nature of their equipment and assured certain repairs; however, the FDA found their analysis and corrective actions insufficient2.
In stock exchange disclosures, Hikal stated it is working closely with the FDA to resolve these issues, does not expect an immediate impact on business continuity or product supply, and has reaffirmed its commitment to compliance with cGMP standards56.
Sources:
1. https://www.statnews.com/pharmalot/2025/09/09/fda-india-hikal-contamination-manufacturing-metal-ingredients-api/
2. https://www.gmp-compliance.org/gmp-news/another-fda-warning-letter-for-indian-api-manufacturer
3. https://scanx.trade/stock-market-news/stocks/hikal-receives-us-fda-warning-letter-for-bengaluru-manufacturing-facility/17325356
5. https://www.business-standard.com/markets/capital-market-news/hikal-slides-after-receiving-usfda-warning-letter-for-jigani-facility-125082200315_1.html
6. https://www.hikal.com/uploads/documents/hikaldiscunderreg30usfdajiganiunit_2.pdf