Seven Indian Brands Behind 1 in 7 US FDA Rejections of Food, Drug, and Cosmetic Shipments

Since October 2020, seven prominent Indian manufacturers—Haldiram, Sun Pharma, Nestlé, Cipla, Patanjali, Hindustan Unilever, and Himalaya Wellness—have accounted for 14% of all India-origin shipments refused entry into the United States by the US Food and Drug Administration (FDA). This statistic is based on FDA data and underscores increasing regulatory scrutiny of Indian exports, particularly in the categories of food, drugs, and cosmetics.

As of early July 2025, the US FDA has already refused 4,089 India-origin shipments in the ongoing fiscal year (October 2024–September 2025), surpassing the 3,648 refusals recorded in the entirety of FY24. Haldiram Snacks Food topped the list, with 731 rejections since 2020, mostly due to alleged unsanitary manufacturing conditions and the presence of Salmonella in snack items. A dramatic 94% of these rejections occurred in FY24 and FY25. Haldiram's refusal rate surged from below 0.1% in FY22 and FY23 to 1.7% in the current period. Singapore’s Temasek, which recently acquired a 10% stake in Haldiram, has not commented on the issue.

Nestlé India followed, with 300 rejected shipments, primarily for misbranding and the presence of unsafe additives in noodle products. Nearly two-thirds of Nestlé’s refusals also occurred in FY24 and FY25. The company has denied responsibility, stating that the flagged exports were not made by Nestlé India. Despite this, Nestlé’s refusal rate rose to 25%, compared to 4% in the previous two fiscal years. In general, the refusal rate for Indian food consignments has doubled from 0.15% in FY22 to 0.32% in FY25.

In the pharmaceuticals category, Sun Pharma has faced 335 FDA rejections since 2020, largely for exporting unapproved drugs and failing to meet good manufacturing practices (CGMP). In June 2025, Sun Pharma received an FDA warning letter following a December 2023 inspection of its Dadra facility, which revealed non-compliance with CGMP norms. Sun Pharma’s refusal rate stands at 1.8% for FY22 to FY25.

Cipla comes next, with 244 rejections in the same period, mainly for similar CGMP violations and unapproved drugs. Cipla’s refusal rate is 1.5% for FY22 to FY25. The refusal rate for all drug and biologic shipments from India increased from 0.7% in FY22 to 1.06% in FY25, making this the second-largest category of refusals (39%) after food.

Patanjali Ayurved leads in cosmetic product rejections, accounting for 20% of the 548 India-origin cosmetic shipments refused since October 2020. The company has a high refusal rate of 11% since FY22, with shampoos, toothpastes, and powders flagged for unsafe color additives, unapproved ingredients, and labeling violations. Patanjali also faced rejections in the food (35) and drug (44) categories.

Hindustan Unilever and Himalaya Wellness saw 51 and 54 rejections, respectively, with refusal rates of 2.1% and 1.2%. Issues included unsafe additives and unapproved drug content.

India’s overall shipment refusal rate rose from 0.21% in FY22 to 0.41% in FY24, slightly declining to 0.36% so far in FY25. India accounts for 17% of global FDA refusals, second only to Sweden (18%), followed by China (12%), although China’s refusal rate remains very low at 0.01%.