Bobbie rebuilt around FDA rules after a recall and relaunched nationwide in 2021
An FDA warning killed Bobbie's first product; the startup took the blame, moved manufacturing to Perrigo in the US, and relaunched with an FDA-reviewed formula.
What was changed
On a June 2019 afternoon, two FDA inspectors visited the San Francisco warehouse of Bobbie, an 18-month-old startup with fewer than 15 employees whose subscription pilot serving about 100 Bay Area customers had launched ten days earlier. The founders had called their German-made product 'toddler formula' or 'companion formula' on the website and packaging, but press coverage — including a Fortune story the inspectors carried, with every mention of 'infant formula' highlighted — placed Bobbie in the infant formula industry, which is governed by the Infant Formula Act's testing and safety rules.
A warning and recall followed; Bobbie called its 100 subscribers and shut down production, becoming, its founders suspect, one of the smallest US companies ever to go through an FDA warning and recall. Instead of fighting, CEO and cofounder Laura Modi had the company write to subscribers that its labeling and marketing 'may have been misleading,' apologize, and put safety first; employees, most of them new parents, even stopped using the powder themselves.
That handling won over two crucial partners. Perrigo, which had declined a cold email months earlier, reached out after noticing how transparently Bobbie communicated — and now makes its formula in Vermont. Wave Capital's Sara Adler, who had passed on the original $2.4 million seed, invested after the recall, calling the team's maturity with the FDA a no-brainer. Under new head of regulatory Christina Berberich, who had handled infant formula regulatory work at Abbott, Bobbie visited the FDA's Silver Spring offices in November 2019 to walk through its revamped US supply chain.
The result was a different product — the recalled formula never returned to market, an FDA spokesperson confirmed — an FDA-reviewed infant formula in a European-style recipe that began shipping nationally on January 5, 2021 at $24.
Why it worked
Modi said the biggest mistake was focusing messaging online without labeling the packaging for children 12 months and up: 'It was just a miss.'
Fighting the agency would have ended the company; as Adler put it, the team asked what the long-term goal was rather than defending a product they had worked to build.
No new infant formula had come to market in the US in five years, and incumbents like Enfamil and Similac had regulatory teams a skeleton crew could not match — so Bobbie hired one.
Transparency toward customers is what re-opened the door with Perrigo and won over Wave Capital, solving manufacturing and funding in one move.
What can be applied
When a regulator moves against you, owning the miss publicly can be the growth strategy: transparency turned a recall into the manufacturing deal and the investment round Bobbie needed.
Aftermath
Bobbie relaunched with 12 employees — who collectively have 19 kids, including six infants — once again using its own product. Modi said the company was in a stronger position than if it had pressed ahead with the original 'companion formula,' and Adler noted that without the FDA acting on the press coverage, Bobbie would not be where it is now.