Seven home producers – Haldiram, Solar Pharma, Nestlé, Cipla, Patanjali, Hindustan Unilever, and Himalaya Wellness – account for one in seven (14 per cent) of all India-origin shipments refused entry into the US by the US Meals and Drug Administration (FDA) since October 2020.
As of early July, the US FDA has refused 4,089 India-origin shipments within the ongoing US fiscal yr 2025 (October 2024 to September 2025) – already exceeding the three,648 refusals recorded in all of FY24, in response to information from the highest public well being regulator.
Haldiram Snacks Meals – through which Singapore’s Temasek acquired a ten per cent stake earlier this yr at a $10 billion valuation – recorded the very best variety of US FDA refusals, with 731 shipments containing Haldiram-manufactured merchandise denied entry since October 2020. Notably, 94 per cent of those rejections occurred in FY24 and the continued FY25, the information exhibits.
Haldiram’s refusal charge – the share of shipments denied over whole shipments despatched – rose to 1.7 per cent in FY24 and FY25 (until July), a pointy soar from beneath 0.1 per cent in FY22 and FY23 mixed. The rejected consignments primarily consisted of snack meals, together with fried objects, flagged for alleged unsanitary manufacturing situations and the presence of salmonella, a disease-causing pathogen.
Haldiram and Temasek didn’t reply to requests for remark.
Nestlé noodles flagged for unsafe components, mislabelling
Within the meals merchandise class, which accounts for 55 per cent of all US FDA refusals since October 2020, Haldiram was adopted by Nestlé India, with 300 shipments rejected. A lot of the consignments contained Nestlé-manufactured noodles, and have been refused entry for misbranding, mislabelling, or containing unsafe components or filth.
Practically two-thirds of those rejections occurred in FY24 and the continued FY25, with Nestlé recording a refusal charge of 25 per cent – greater than 5 instances the 4 per cent in FY22 and FY23. Whereas the US FDA information lists Nestlé India because the agency behind these consignments, an organization spokesperson instructed The Indian Categorical that these exports weren’t made by Nestlé India and that no refusals have been recorded within the latest previous.
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The refusal charge of all meals consignments from India stands at 0.32 per cent in FY25, up from 0.15 per cent in FY22.
Solar Pharma, Cipla face FDA warmth
Within the medication and biologics class, Solar Pharma led with 335 cargo rejections since October 2020 – largely for exporting unapproved medication or failing to fulfill good manufacturing requirements. Its refusal charge between FY22 and the continued FY25 stands at 1.8 per cent.
In June 2025, the US FDA issued a warning letter to Solar Pharmaceutical Industries Ltd over “important violations” of Present Good Manufacturing Observe (CGMP) rules for completed medication. The letter adopted a December 2023 inspection of the corporate’s Dadra facility, which discovered that some exported merchandise have been adulterated attributable to non-compliance with CGMP norms.
Solar Pharma is adopted by Cipla, which has recorded 244 rejections since October 2020, primarily for exporting unapproved medication. Cipla’s refusal charge between FY22 and the continued FY25 stands at 1.5 per cent. In November 2023, the US FDA had issued a warning letter to Cipla Ltd, too, for non-compliance with CGMP norms.
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The refusal charge of all medication and biologics shipments from India has risen in recent times, from 0.7 per cent in FY22 to 1.06 per cent thus far in FY25. These consignments account for 39 per cent of all refusals since October 2020, the second-largest class after meals merchandise.
Solar Pharma and Cipla didn’t reply to requests for remark.
Patanjali tops beauty refusals
Whereas beauty cargo rejections by the US FDA make up a small share – simply 3 per cent, with 136 refusals thus far in FY25, trailing 156 in FY24 – Patanjali Ayurved has recorded a excessive refusal charge of 11 per cent since FY22, information exhibits.
Of the 548 India-origin beauty shipments refused since October 2020, practically 20 per cent contained Patanjali-manufactured merchandise – largely shampoos, toothpastes and powders, and hair tonics. The most typical causes for rejection embody using unsafe color components, unapproved substances, and labelling violations. Along with cosmetics, Patanjali shipments have additionally confronted rejections within the medication (44) and meals (35) classes.
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Hindustan Unilever and Himalaya Wellness have confronted 51 and 54 cargo rejections, respectively, since October 2020, with refusal charges of two.1 per cent and 1.2 per cent since FY22. Most of their consignments have been flagged for holding unsafe color components or unapproved medication. Hindustan Unilever additionally recorded 23 refusals within the meals class and eight in medication.
Patanjali, Hindustan Unilever, and Himalaya didn’t reply to requests for remark.
The general refusal charge for Indian beauty shipments rose from 0.16 per cent in FY22 to 0.48 per cent in FY24, earlier than easing to 0.2 per cent thus far in FY25.
The refusal charge for India-origin shipments throughout all classes has climbed in recent times – from 0.21 per cent in FY22 to 0.41 per cent in FY24, earlier than easing barely to 0.36 per cent thus far in FY25.
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Within the ongoing US fiscal, India accounts for 17 per cent of all FDA refusals – second solely to Sweden at 18 per cent. Swedish shipments, largely consisting of tobacco merchandise, had a notably excessive refusal charge of 1.7 per cent. China adopted with a 12 per cent share of whole rejections, however its general refusal charge was simply 0.01 per cent.