Seven brands account for 1 in 7 US FDA refusals of Indian food, drug, cosmetic shipments
In a startling revelation that underscores rising scrutiny of Indian exports, the United States Food and Drug Administration (US FDA) has refused over 4,000 shipments from India between October 2020 and July 2025. What’s even more alarming is that just seven Indian brands are responsible for 1 in every 7 refusals, raising red flags about the quality, safety, and regulatory compliance of some of India’s most well-known products.
The brands under the FDA scanner include Haldiram, Nestlé India, Patanjali, Sun Pharma, Cipla, Himalaya Wellness, and Hindustan Unilever. These companies represent a broad swath of India’s food, pharmaceutical, and cosmetic sectors—yet their growing list of rejections highlights persistent gaps in product safety, manufacturing hygiene, labeling accuracy, and adherence to international standards.
Haldiram: From Household Favorite to Rejection Leader
Haldiram, the popular Indian snack manufacturer, has emerged as the most refused brand, with over 730 shipment rejections in less than five years. According to US FDA data, the vast majority of these refusals occurred in FY24 and FY25, primarily due to unsanitary production conditions, improper packaging, and salmonella contamination.
Despite its strong domestic reputation, Haldiram’s rejection rate spiked dramatically—rising from less than 0.1% in earlier years to nearly 1.7% in recent months. The brand now faces growing pressure to strengthen food safety protocols and overhaul export practices.
Nestlé India: Instant Noodles Under the Microscope
Nestlé India, another high-profile brand, has seen nearly 300 of its noodle shipments rejected by the FDA. The rejections were often tied to misbranding, mislabeling, or the inclusion of unauthorized food additives. While Nestlé India has denied that these products originated from their official operations, the frequency and nature of the violations raise questions about third-party vendors, supply chain oversight, and export documentation.
Refusal rates for Nestlé’s exports skyrocketed to around 25% in the last two years—a worrying sign for a company that heavily depends on global trust and consumer safety assurances.
Patanjali: Cosmetic Refusals Surge
Ayurvedic giant Patanjali Ayurved leads the list in the cosmetics category, accounting for almost 20% of the 548 cosmetic-related shipment refusals since 2020. The rejections stemmed from unsafe ingredients, unapproved color additives, and improper labeling, violating US cosmetic regulations.
Moreover, Patanjali also saw 44 drug shipment refusals and 35 food shipment rejections, signaling that compliance issues extend beyond just one vertical. As regulatory authorities intensify their oversight, Patanjali’s commitment to Ayurvedic authenticity must now be matched with international safety compliance.
Sun Pharma and Cipla: Drug Manufacturing Woes
Two of India’s largest pharmaceutical firms—Sun Pharmaceutical Industries and Cipla—are facing significant regulatory setbacks in the US, one of their most lucrative markets.
Sun Pharma had over 330 shipments refused, largely for unapproved drug formulations and CGMP (Current Good Manufacturing Practice) violations. In June 2025, the FDA even issued a warning letter to its Dadra facility, citing critical lapses in sanitation, testing, and documentation.
Similarly, Cipla saw 244 refusals, with rejection rates around 1.5%. A warning letter in November 2023 also highlighted deficiencies in production environments and batch testing. These regulatory actions serve as a reminder that global drug exports must be backed by consistent quality control—not just scale.
Himalaya and Hindustan Unilever: Cosmetics and More
Himalaya Wellness and Hindustan Unilever (HUL) also found themselves on the list, with 54 and 51 refusals, respectively. HUL faced rejections in all three categories—food, drug, and cosmetics—due to issues ranging from unsafe additives to mislabeling.
While these numbers are lower than those for Haldiram or Sun Pharma, they still indicate lapses in quality monitoring, especially when it comes to products formulated for Western markets.
FDA Trends: India Under the Regulatory Lens
The FDA refusal data reveals a broader trend: India’s refusal rate has steadily risen from 0.21% in FY22 to 0.41% in FY24, with a slight drop to 0.36% in FY25. Notably, India now accounts for 17% of all US FDA refusals, second only to Sweden (18%).
By product category:
- Food items make up 55% of total rejections, with major concerns around contamination and packaging hygiene.
- Drugs and biologics account for 39%, largely due to unapproved formulations and manufacturing quality lapses.
- Cosmetic products, while a smaller slice, have seen refusal rates triple over the last three fiscal years.
What This Means for Indian Exports
This surge in FDA refusals underscores a key message for Indian manufacturers: global reputation must be earned through strict compliance. Even brands with decades of goodwill are now at risk if they fail to meet international standards.
Exporters must invest more in:
- Sanitation and testing protocols
- Accurate product labeling
- Regulatory training for staff
- Independent audits of manufacturing units
The world’s regulatory landscape is becoming more vigilant, and companies can no longer rely solely on brand value or market presence. Trust in international trade is built not only on tradition but also on transparency, traceability, and tested quality.
Conclusion
The US FDA’s rising refusal rates should be a wake-up call for India’s food, pharmaceutical, and cosmetic exporters. While the contributions of Indian brands to global markets remain substantial, so too must their commitment to quality. Strengthening regulatory compliance is not just a legal obligation—it is a strategic necessity for long-term global success.
