The federal government is asking a Minnesota judge to do something the FDA rarely asks for and courts rarely order: shut a distributor down. On September 11, the Department of Justice filed suit in the U.S. District Court for the District of Minnesota seeking a permanent injunction against Gold Star Distribution, Inc., the Minneapolis wholesaler whose December recall pulled roughly 2,000 food, drug, and cosmetic products from about 50 stores in three states. The requested order would bar the company from receiving, storing, or distributing regulated products at its current warehouse, or any future one, until the FDA is satisfied the operation complies with federal law.
The complaint, reported first by FOX 9, is the latest and furthest step in an eight-year escalation. Its allegations are just that: allegations in a complaint, which a court has not yet weighed. The company has not filed an answer.
What the Complaint Describes
Gold Star Distribution operates a warehouse on Humboldt Avenue North in Minneapolis, supplying mostly halal markets and small groceries across Minnesota and the Midwest. About three quarters of what moves through the building is regulated by the FDA: infant formula, over-the-counter medicines like Tylenol and Advil, medical devices, cosmetics, rice, and pet food.
According to the complaint, a five-week FDA inspection from November 17 to December 18, 2025 documented conditions that read like an inventory of a failing building: nine live rodents and seventeen dead ones in varying stages of decay; eight live birds and one dead one; worms on the floor; droppings the inspectors described as too numerous to count; urine stains; gnaw holes and nesting material near pallets of rice, cat food, bottled tea, drugs, sanitary pads, and soap. The complaint says bird droppings landed on packaged tea bottles, trash leaked and overflowed near outgoing shipments, dock doors had gaps, holes opened in a wall, and two ceiling leaks dripped onto stored product. There was no temperature monitoring for drug storage.
The product list matters because of who buys it. The complaint names infant formula, including Enfamil, over-the-counter medicines, pregnancy tests, and personal-care items among the goods held in the building, FOX 9 reported. These are not luxury goods. They are staples for households and for the small markets that supply them.
FDA laboratory analysis, the complaint continues, confirmed rodent urine, droppings, hairs, and gnawed packaging on products. The health risk alleged is contamination with bacteria such as Salmonella. The FDA's recall announcement from December states plainly that no illnesses had been reported.
The inspection closed with a Form 483 listing nine observations, the agency's written notice of conditions it considers objectionable. A 483 is not a final determination; it is the opening of the record the lawsuit now builds on. The complaint's allegations will be tested against that record, and against whatever the company's own evidence shows about the building's condition.
Eight Years of Escalation
The lawsuit did not come out of nowhere. It is the top of a ladder the agency climbed one documented step at a time.
The first rung was a warning letter in October 2018, after a July 2018 inspection found the same species of problems: rodent droppings too numerous to count, laboratory-confirmed rat hairs, dead rodents, live birds, gnawed food cases, and a leaking roof with water reaching infant formula. The 2018 details were similarly specific: leaked bleach had burned holes through boxes of cheese curls, and cream cheese sat unrefrigerated. The warning letter cited adulteration and warned of possible seizure or injunction. That warning sat eight years ahead of the filing that finally arrived. The FDA closed the letter after the company made voluntary corrections, but an April 2019 inspection found the company still had not excluded pests, the Star Tribune has reported.
The state track ran alongside. The Minnesota Department of Agriculture has documented pest problems since 2012. Between 2018 and 2025 the state issued three warning letters and two monetary penalties and imposed a two-year license-limitation agreement with stepped-up inspections. It revoked the company's wholesale license in November 2025. The state record matters to the federal case: the FDA's complaint recites the company's regulatory history as evidence that the violations are chronic rather than episodic, which is the difference between a fixable lapse and a business model.
Then came the recall. On December 26, 2025, the company voluntarily recalled all FDA-regulated products held at the facility, a list of roughly 2,000 items distributed to stores in Minnesota, Indianapolis, and Fargo. The FDA classified the recall as Class II, its middle tier for products that may cause temporary or medically reversible harm and are unlikely to cause death or serious injury. The classification describes the agency's risk judgment, not the scale of the recall. Two thousand products across three states is an extraordinary withdrawal for a single warehouse; the Class II label is what kept it off the front pages for most of the winter.
The lawsuit followed in September. The gap between the recall and the filing is part of the story: the company sent the FDA three responses in January and February describing sealing dock and entry doors, spill training, a third-party expert, refuse-area cleaning, and a possible renovation or relocation. The government's complaint calls those measures inadequate: no root-cause analysis, no adequate pest-control plan, and no evidence that structural changes or a move happened.
The Company's Position
The company has told its side of the story in public, through the Star Tribune. Owner Bassam Abu Samrah said the infestation began with rice loads that arrived already infested, and with birds that got in through the building's openings. He said he felt targeted by regulators and that the business planned to move to a new facility.
The injunction the government wants would reach that new facility too. The requested order bars distribution at the current location "or any future location" until the company complies to the FDA's satisfaction. The building itself is effectively the defendant. A move does not resolve the case; only demonstrated compliance does.
For the stores and families who bought from Gold Star for years, many of them small halal markets, the outcome matters twice over: the recall already emptied their shelves of staple products, and a permanent injunction would remove a supplier entirely. The FDA's job is to protect the people who buy those products. The court's job is to decide whether the government has shown that only an injunction protects them.
The Stores That Depend on the Warehouse
Gold Star's customers were mostly small grocers and halal markets across the Twin Cities and the upper Midwest, the Star Tribune reported during the recall. For those stores, the recall was not an abstract list of 2,000 items. It was empty shelves where staples had been, and refund paperwork for customers who had already bought. A permanent injunction would remove the supplier entirely, not just the tainted stock.
That is the other side of the enforcement ledger. The FDA's job is to protect the people who buy the products, and an eight-year record of the same violations argues that only a court order will do it. The stores' reality is that their supplier, whatever its flaws, is the one they have. Both facts can be true at once, and the court's order will have to live with both.
What the Lawsuit Is For
The statute under which the government sued, Section 332 of the Food, Drug, and Cosmetic Act, is the agency's enforcement ceiling: an injunction against a business the agency cannot otherwise bring into compliance. It is rare precisely because it is heavy. Most warning letters end in corrections, and most recalls end in lessons. This case is what happens when the earlier steps do not stick.
The procedural details reinforce how serious the filing is. The government did not request a summons, which is unusual; it wants the court to act directly on the injunction request. The standard is steep: the government must show violations and a reasonable likelihood they will continue unless the court orders otherwise. The complaint argues that the inspections, the warning letter, the recall, and the company's own responses all point to that likelihood. The company's account points the other way: the problems, it says, originated in infested loads that arrived at the dock and birds that entered through the building's openings, and a move to a new facility was already planned.
Eight years will be read by each side as vindication. The government will say the record proves compliance never lasted. The company will say the record proves it kept trying while regulators kept escalating. The judge will have to decide which reading the building's history supports. The recall notice's most important line remains the one about illnesses: none reported. The lawsuit's most important question is whether the next inspection finds what the last one did, and the injunction asks the court to settle that question before anyone gets sick.
Primary sources
- FOX 9 (KMSP), "Feds sue Gold Star Distribution to cease operations until company complies with health regulations," for the complaint's allegations, the recall scope, and the company's responses to the FDA.
- FDA recall announcement, Dec. 26, 2025, for the recalled product categories, the three states, and the no-illnesses-reported statement.
- FDA warning letter CMS 562931, Oct. 19, 2018, for the 2018 inspection findings.
- Star Tribune coverage of the recall and the warning-letter history, for the state enforcement record and the owner's account.
- Complaint, United States v. Gold Star Distribution, Inc., No. 0:26-cv-03976 (D. Minn.), for the relief sought and the 2025 inspection findings.