By Team INVC | INVC NEWS
NEW DELHI, India | September 18, 2026 —
India’s food safety regulator has initiated legal action against Nestlé India after laboratory reanalysis found a sample of an infant follow-up formula substandard because it did not meet the prescribed requirement for biotin, also known as vitamin B7. The development has put Nestlé’s infant nutrition business under renewed regulatory scrutiny.
The Food Safety and Standards Authority of India, or FSSAI, has also initiated adjudication proceedings involving claims and labelling associated with two other infant nutrition products — NAN Excella Pro Stage 1 and Lactogen Pro 1. Nestlé India has disputed the regulator’s allegations and maintains that its products comply with applicable Indian regulations.
What did FSSAI find?
The most significant issue concerns a sample of a Nestlé follow-up formula intended for infants.
According to the regulator, reanalysis of the sample confirmed that its biotin content did not meet the level prescribed under Indian food standards. FSSAI subsequently initiated legal action over the alleged non-compliance.
Biotin is vitamin B7, an essential nutrient involved in normal metabolic processes. However, the regulatory action concerns whether the sampled product complied with India’s prescribed nutritional standard; it should not be interpreted as evidence that every Nestlé infant nutrition product has failed testing.
NAN Excella Pro and Lactogen Pro also face proceedings
FSSAI’s action extends beyond the laboratory finding.
The regulator has initiated separate adjudication cases involving NAN Excella Pro Stage 1 and Lactogen Pro 1 over allegedly non-compliant promotional or labelling claims. Reports say claims scrutinised by the regulator included references to “5 HMOs” and whey protein.
Overall, FSSAI has initiated three adjudication cases concerning Nestlé India infant nutrition products.
Nestlé India rejects non-compliance allegations
Nestlé India has challenged the regulator’s position.
The company says NAN Excella Pro and Lactogen Pro comply with applicable regulations. It has also maintained that labels now under scrutiny had previously received approval from an FSSAI expert committee.
That response is important because the regulatory proceedings have begun, but the contested issues have not yet reached a final adjudicated outcome.
Has Nestlé baby formula been recalled in India?
No recall has been announced in connection with this latest FSSAI action in the information currently available.
This distinction matters for parents and caregivers. FSSAI’s action over a substandard sample and separate labelling allegations should not be confused with an order recalling all Nestlé infant formula products from the Indian market. Reuters reported that the regulator had not indicated whether a recall would follow.
Nestlé India had separately said in January that infant-formula batches recalled or withdrawn in some overseas markets at that time were not imported or sold in India and that its Indian infant-formula brands were manufactured locally. That earlier international recall is a separate matter from today’s FSSAI proceedings.
Nestlé India shares react
The regulatory development also reached the stock market. Nestlé India shares fell following reports of the FSSAI action, reflecting investor attention on the potential regulatory and reputational implications for one of the company’s important product categories.
The immediate financial impact, however, will depend on how the adjudication proceedings develop and whether regulators subsequently announce penalties, corrective measures, product-specific directions or any other enforcement action.
What should consumers know?
Parents should distinguish between a regulatory non-compliance proceeding and a product recall.
At present, available reporting does not establish that all Nestlé baby formula sold in India is unsafe, nor has FSSAI announced a nationwide recall connected with today’s action. Consumers should therefore avoid acting on unverified social-media claims suggesting that every Nestlé infant nutrition product has been banned or recalled.
Any parent concerned about an infant’s nutrition or formula should seek guidance from a qualified healthcare professional rather than abruptly changing an infant’s feeding plan solely because of social-media reports.
The next major development will be whether FSSAI issues additional product or batch-specific directions, imposes penalties through adjudication, orders corrective labelling, or announces any recall.
Until then, the central fact remains clear: India’s food regulator has escalated its scrutiny of Nestlé India’s infant nutrition products into formal legal proceedings, while Nestlé continues to contest the allegations.
