The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, importers, distributors and caregivers to the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the US due to contamination concerns.

In a public alert issued on Saturday, the agency said it received notification that the United States Food and Drug Administration had announced the recall following reports of foreign material in the product.

According to NAFDAC, the recall was initiated by Strides Pharma Inc. after consumers complained of a “gel-like mass” and “black particles” in the oral suspension.

Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is commonly used to relieve pain associated with the common cold, flu, sore throat, headache and toothache in children, and to reduce fever.

Health risks

NAFDAC warned that the presence of foreign material in medicinal products could compromise their quality, safety and effectiveness.

The agency noted that administering contaminated oral suspensions may result in adverse reactions, particularly among children, and could pose choking or gastrointestinal risks depending on the nature of the contaminant.

Affected products

The affected product is Children’s Ibuprofen Oral Suspension, USP, 100 mg/5 mL, packaged in 120 mL (4 fl. oz.) bottles.

The product was manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals U.S.A., Inc.

NAFDAC said the affected batches are lot numbers 7261973A and 7261974A, with an expiry date of 31 January 2027.

The recalled products were distributed nationwide in the US.

Surveillance in Nigeria

Although the affected products were distributed and recalled within the US, NAFDAC said it is taking precautionary measures to prevent them from entering Nigeria through authorised or unauthorised channels.

The agency said it had directed all its zonal directors and state coordinators to intensify surveillance activities and remove the products from circulation if found in their jurisdictions.

“NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety and efficacy of medicines circulating in Nigeria,” the agency said.

Advice to healthcare providers, parents

NAFDAC advised importers, distributors, retailers and healthcare professionals to remain vigilant and ensure that medical products are sourced only from authorised and licensed suppliers.

The agency also urged healthcare facilities to immediately inspect their inventories and quarantine any affected batches if identified.

Parents and caregivers who possess the recalled products, or who may have administered them to children, were advised to stop using them immediately and seek medical attention if any unusual reactions are observed.

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NAFDAC further encouraged healthcare professionals and members of the public to report adverse reactions associated with medicinal products through its pharmacovigilance channels, including its e-reporting platform and the Med Safety mobile application.

The agency said reports could also be submitted through the nearest NAFDAC office or via its designated pharmacovigilance email address.

Anthropic’s sudden move to suspend access to its newest AI models following a U.S. government directive has raised fresh questions across the global technology industry. In India, the decision has reignited a long-running debate over whether one of the world’s largest AI markets can afford to rely on technologies built and controlled elsewhere.

The announcement came late Friday, when Anthropic said it had received the U.S. government directive requiring it to suspend access to its recently launched Fable 5 and Mythos 5 models for all foreign nationals, including its own foreign national employees. The move came shortly after the company announced a partnership with Indian IT services giant Tata Consultancy Services to expand enterprise AI adoption in India, underlining how closely the country’s AI ambitions have become tied to technologies developed and governed in the U.S.

While the broader implications remain unclear, some reports said the initial security concerns were first reported to the government by Amazon CEO Andy Jassy. And The Information said the White House is unlikely to extend similar restrictions to other AI companies and is privately blaming Anthropic’s handling of alleged jailbreak vulnerabilities. Anthropic has disputed the government’s characterization and argued the action should not have been taken.

Regardless, the development has triggered debate among Indian founders, investors, and policy experts over whether the country should accelerate efforts to build domestic AI capabilities, deepen investment in open-source alternatives, or continue relying on a handful of U.S. frontier model providers. For some, the episode is a wake-up call on technological dependence. For others, it is a reminder that access to increasingly critical AI systems can be shaped by geopolitical decisions beyond India’s control.

India has become one of the most important markets for frontier AI companies. Anthropic and OpenAI have both described the South Asian nation as their second-largest market after the U.S., reflecting its growing importance in the global AI race. The companies have already set up their offices in India, expanded local hiring, partnerships, and enterprise initiatives in recent months, betting on India’s vast base of developers, startups, and businesses to accelerate adoption of their latest technologies.

For many in India’s technology sector, Anthropic’s Friday announcement was about more than just one AI company. It reopened questions about the country’s long-term AI strategy and whether India could afford to remain dependent on a small number of foreign frontier AI providers.

“It completely changes things,” said Aakrit Vaish, founder of Indian AI venture platform Activate, referring to Anthropic’s decision. “I think this materially changes the way all of us should be thinking about sovereign AI in India.”

Vaish told TechCrunch that he woke up on Saturday morning “shocked and confused” by the announcement and said it strengthened the case for developing domestic AI capabilities. He expects startups to increasingly turn to open-source models and plans to encourage companies in his portfolio to reduce their dependence on a small number of frontier AI providers.

For some founders, the bigger concern was what restrictions on frontier AI access could mean for competitiveness. Vijay Rayapati, co-founder and CEO of Atomicwork, told TechCrunch that the episode highlighted the risks facing startups whose teams span multiple countries if access to advanced AI systems increasingly becomes subject to geopolitical restrictions.

Atomicwork has around 25 employees in the U.S., though much of its product engineering team is based in Bengaluru, India.

“If your AI team is not made up entirely of U.S. citizens, you are at a competitive disadvantage,” Rayapati said, arguing that unequal access to frontier AI models could give some companies a significant edge over rivals.

The concern comes as parts of India’s tech sector are already grappling with questions about how AI could reshape the economics of global talent. This week, U.S. real estate technology company Opendoor shut its India office less than two years after expanding in the country, with CEO Kaz Nejatian citing a push to bring operational work closer to customers in the U.S. and a shift toward smaller AI-native teams.

While Opendoor did not specify how much of the decision was driven by AI-related efficiencies, the move added to a broader debate about how advances in AI could affect the future of global technology work and what that might mean for India’s position as an engineering talent hub.

Beyond Anthropic

In addition to startups and AI builders, the Anthropic episode also prompted a broader debate among India’s technology leaders about dependence on foreign AI infrastructure.

Sridhar Vembu, founder of Indian SaaS company Zoho, said the move showed that “technology is the ultimate weapon” and urged Indian organizations to increasingly embrace smaller and open-source models.

“What can our government do right now? Ensure that orgs in India embrace smaller models, both Indian and Chinese open source ones,” Vembu wrote on X.

Investor and former Infosys executive Mohandas Pai responded to Vembu on X, arguing that the development highlighted the need for a far more ambitious national AI strategy and calling on the government to substantially increase investments in AI, computing infrastructure, and deep technology.

“We are way behind and need a national mission to get going quickly,” Pai wrote, urging the government to create an annual ₹500 billion (about $5 billion) fund for AI and deep tech, alongside a ₹2 trillion (around $21 billion) credit guarantee program to support cloud infrastructure, hardware, and semiconductor development.

Pai’s proposal would dwarf India’s existing AI efforts. In 2024, New Delhi approved the IndiaAI Mission with an outlay of ₹103.72 billion (about $1.2 billion) over five years, aimed at expanding compute infrastructure, supporting startups, and developing indigenous AI capabilities.

Despite growing interest in AI and New Delhi’s push to develop domestic capabilities, India remains a relatively small player in frontier model development. Only a handful of startups are pursuing foundational AI models, including Sarvam, which released open-source models earlier this year. However, another high-profile AI startup, Krutrim, pivoted toward cloud and AI infrastructure services after initially positioning itself around foundational model development.

Much of India’s AI ecosystem has instead concentrated on applications and specialized models built on top of existing foundation models. Recent examples include Avataar AI, which launched a video-generation model earlier this week aimed at providing a lower-cost alternative to offerings from rivals including Google’s Veo, Kling, Luma, and Runway.

Not everyone agrees that the primary challenge is a lack of capital. Responding to Pai’s comments, Lightspeed partner Hemant Mohapatra argued that the biggest constraints to building globally competitive AI companies are talent, access to computing resources, and execution, rather than simply the size of investment commitments.

Mohapatra estimated that training a frontier AI model could cost anywhere from hundreds of millions to several billion dollars, depending on the approach, but said successful AI companies have historically scaled their capital requirements over time as adoption grew.

Yet for some policy observers, the implications extend well beyond AI startups or model providers.

Prasanto Roy, a New Delhi-based technology policy expert who advises multinational companies, said the episode would likely reinforce concerns within the Indian government about strategic autonomy, comparing it to the lesson many countries drew from Russia’s loss of access to SWIFT and other parts of the global financial system following its invasion of Ukraine.

He told TechCrunch that the move was likely to provoke a significant nationalist backlash in India and described it as a poorly considered decision by Washington, with consequences extending far beyond Anthropic itself.

“Even if this is corrected or reversed, the Anthropic episode shows there’s no such thing as a geopolitically neutral foreign LLM,” Roy said. “American AI models are bound to American geopolitics.”