STURGIS, Mich. — Abbott Nutrition restarted infant-formula production at its Sturgis, Michigan, facility Saturday after meeting initial requirements set under a federal consent decree, beginning a closely watched effort to restore domestic supply following a shutdown that helped deepen a nationwide shortage.

Abbott said it is starting with EleCare and other specialty metabolic formulas for children with severe allergies and gastrointestinal conditions. In its June 4 production update, the company said it would ramp output as quickly as possible while complying with the agreement and expects initial EleCare product from the restarted plant to begin reaching consumers around June 20.

The restart follows months of recall, inspection and remediation

The Sturgis plant stopped producing powdered formula after Abbott initiated a February recall of certain Similac, Alimentum and EleCare products while federal authorities investigated reports of Cronobacter sakazakii infections in infants. The facility’s shutdown removed a major source of U.S. powdered formula at a time when the broader supply chain was already strained.

Abbott and the Food and Drug Administration reached a reopening framework in May. In a May 16 announcement, Abbott said the consent decree established conditions for resuming operations, including corrective actions, sanitation changes, environmental monitoring and oversight by an independent expert.

The Justice Department’s complaint and proposed consent decree alleged that powdered formula had been manufactured under conditions that did not comply with federal food-safety requirements and noted that FDA environmental sampling detected Cronobacter in the facility. The agreement requires outside expertise, testing and ongoing FDA supervision as production resumes.

Restarting the plant does not immediately refill store shelves

Powdered infant formula requires production, drying, testing, packaging and distribution before it reaches retailers. Abbott had previously estimated that products could take six to eight weeks to reach shelves after a restart, although the company is prioritizing some specialty products on a faster schedule.

On May 24, Abbott announced that it would release limited quantities of previously manufactured EleCare after additional testing and said it planned to restart Sturgis on June 4. The company said specialty formula would be produced first because some children depend on amino-acid-based products that cannot easily be substituted with conventional formula.

The restart therefore represents a supply-chain turning point rather than an immediate resolution. A June 4 report noted that families could continue facing shortages for weeks even as production resumes, because new batches must pass testing and move through distribution networks.

Federal agencies are pursuing parallel ways to increase supply

FDA has also temporarily widened the path for formula made outside normal U.S. channels. On May 16, the agency issued an enforcement-discretion policy allowing case-by-case consideration of products from manufacturers that can demonstrate safety and nutritional adequacy even if some labeling or other regulatory requirements differ from standard U.S. rules.

The administration has additionally invoked the Defense Production Act to give formula manufacturers priority access to needed inputs and launched Operation Fly Formula to move qualifying foreign supplies into the United States by air. Those measures are intended to bridge the period before domestic production returns to normal and diversify sources in a market dominated by a small number of manufacturers.

The shortage has exposed the fragility of a system in which a disruption at one large facility can quickly affect national availability. Formula is not an ordinary consumer product: for many infants it is the sole or primary source of nutrition, and specialized formulas may be medically necessary for children who cannot tolerate standard products.

Safety scrutiny remains as important as production speed

The urgency to restore supply does not remove the regulatory questions that led to the shutdown. The consent decree requires Abbott to operate under enhanced controls and gives FDA a continuing oversight role. If contamination or other serious problems are identified, production may have to stop again while corrective action is taken.

Abbott has said its investigation found no conclusive evidence linking distributed formula to the illnesses that triggered the federal investigation, and it has emphasized that retained product samples tested negative for the pathogens of concern. Federal officials, however, documented sanitation and environmental-control problems at Sturgis, which is why the restart is occurring under court-enforceable conditions rather than a simple return to ordinary operations.

The distinction is important for parents: resuming production is not a declaration that the earlier concerns were insignificant. It reflects a regulatory judgment that Abbott has met initial reopening requirements and can begin manufacturing while continuing to satisfy additional testing, monitoring and expert-review obligations.

The measure of success will be reliable supply without sacrificing quality

Abbott’s plant is now running again, but the shortage will ease only as safe product moves from factories to warehouses, pharmacies and grocery shelves. Specialty formula is the first priority; Similac and other mainstream products are expected to follow as Abbott completes the steps required to restart those lines.

The federal enforcement-discretion program and imported shipments may provide additional relief in the meantime. Together, those efforts are designed to reduce dependence on a single production restart and increase near-term options for hospitals, pediatric practices and families.

Saturday’s reopening is nevertheless one of the most consequential steps since the shortage became a national crisis. The plant whose closure removed a major share of U.S. powdered-formula capacity is producing again. The next test is whether Abbott and regulators can sustain that production under tighter controls and translate it into dependable availability for families without weakening the food-safety standards that prompted the shutdown in the first place.