TL;DR
- Company: Allandale Dairy, Pierz, Minnesota — co-owned by Shane D. Stangl, Scott Stangl, and Craig Stangl.
- Date: FDA Warning Letter, CMS #727610, issued June 23, 2026; posted to fda.gov July 14, 2026.
- Classification: FDA Center for Veterinary Medicine (CVM) — food adulteration via new animal drug residue, plus extralabel drug use.
- Key citations: FD&C Act § 402(a)(2)(C)(ii) (21 U.S.C. § 342(a)(2)(C)(ii)), tied to § 512 (21 U.S.C. § 360b); 21 CFR 556.640(b)(2)(i) (0.1 ppm sulfadimethoxine tolerance in cattle edible tissue); 21 CFR Part 530 (extralabel drug use under AMDUCA, 1994).
- Consequence: 15 working days to respond in writing; as of the letter's date, FDA states it had received no response to the underlying Form FDA 483.
| Company | Location | Reference | Issued | Issuing Office | Inspection Dates | Classification |
|---|---|---|---|---|---|---|
| Allandale Dairy | Pierz, MN | CMS #727610 | June 23, 2026 | Center for Veterinary Medicine | March 3, 11 & 19, 2026 | New Animal Drug / Adulterated |
What does it take for a warning letter to name a working dairy farm instead of a pharmaceutical plant? One number: 0.116. That's the parts-per-million reading FDA's own testing found in the liver tissue of a cow Allandale Dairy sold for slaughter, against a tolerance of 0.1 ppm. Sixteen-thousandths of a part per million over the line, and the letter that followed reads nothing like the CGMP cases that fill most of this database.
FDA's June 23, 2026 warning letter to Allandale Dairy, CMS #727610, is addressed to co-owners Shane D. Stangl, Scott Stangl, and Craig Stangl at their Pierz, Minnesota operation. It's also this pipeline's first letter from FDA's Center for Veterinary Medicine (CVM). Every prior entry in this database came from CDER, CDRH, or CBER, agencies that regulate what happens inside a manufacturing plant. CVM regulates what happens on a farm, and the violations it cites look correspondingly different: no contaminated cleanroom, no falsified lab form, no unauthorized device size. Just a residue reading over tolerance, and paperwork that couldn't account for how a drug was actually dosed.
Violation 1: an adulterated animal, by the numbers
FDA's inspectors, working from USDA/FSIS tissue-sample testing, found sulfadimethoxine at 0.116 ppm in the liver of a cow Allandale Dairy sold at auction for slaughter. FDA's own tolerance for sulfadimethoxine in cattle edible tissue, excluding milk, is 0.1 ppm, set out at 21 CFR 556.640(b)(2)(i). Milk carries a tighter tolerance still, 0.01 ppm, under the same section. The cow's tissue came in above the cattle-tissue line, full stop.
That single reading does real legal work. Under FD&C Act § 402(a)(2)(C)(ii), 21 U.S.C. § 342(a)(2)(C)(ii), food is adulterated if it bears or contains a new animal drug that is unsafe within the meaning of § 512 of the Act, 21 U.S.C. § 360b. A drug residue above its established tolerance is, by definition, unsafe under that framework. The statute doesn't ask whether the farm intended to sell contaminated meat, or whether the margin over tolerance was large or small. It asks whether the residue exceeded the number FDA set. Here, it did.
FDA's letter adds a second, independent basis for the same adulteration finding: the firm's treatment records did not consistently document which condition was treated, the route of administration, or who administered the drug to a given animal. FDA treats that gap as its own problem, separate from the residue reading, because incomplete records make it impossible to verify that a treated animal cleared its required withdrawal period before entering the food supply. An animal held under conditions where medicated residues are likely to reach consumers is adulterated on that basis alone, whether or not a specific residue test later confirms it.
Violation 2: dosing that didn't match the label or the prescription
The letter's second heading, "Adulteration of New Animal Drugs," addresses how the drugs were used rather than what showed up in tissue. FDA found Allandale Dairy administered Sulfadimethoxine Injection 40% and a flunixin meglumine injection to dairy cattle in ways inconsistent with the products' approved labeling and the treating veterinarian's own prescription. Use of an approved animal drug in a manner the label doesn't authorize is extralabel use, a practice that is only lawful within the specific conditions set out in 21 CFR Part 530, implementing the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). AMDUCA permits extralabel use of an approved drug, but only by or on the lawful order of a veterinarian, inside a valid veterinarian-client-patient relationship, and consistent with that veterinarian's specific dosing order.
The letter documents the labeled dose for Sulfadimethoxine Injection 40%: 25 mg/lb for the initial dose, 12.5 mg/lb for maintenance. It then documents that the firm's own treatment records, cross-checked against a statement from Shane Stangl, show the maintenance dosing didn't track that schedule for at least one identified animal. A separate example in the letter shows a weight mismatch: the dose given corresponds to a cow FDA calculates at 960 lbs, a different figure from the weight the farm had recorded for that animal at treatment. Several exact figures in the public letter are redacted under a FOIA commercial-information exemption, marked (b)(4) in the letter text, so this analysis doesn't assume specifics the record doesn't show. What the unredacted portions establish is enough on their own: the dosing didn't match either the label or the prescribing veterinarian's order, which is the exact condition AMDUCA and Part 530 require to keep extralabel use lawful.
Why this letter still matters if you don't run a dairy
Nothing here involves a cleanroom, a validated assay, or a quality management system. It's a farm-level letter, and it would be easy for a pharma or device compliance officer to read the classification and move on. That would be a mistake for one specific reason: this database has already tracked a warning letter naming a distribution platform for a violation with no manufacturing defect at all (Amazon.com, unapproved new drugs via Fulfillment by Amazon). CVM's enforcement logic runs on the same principle, applied to a supply chain that plenty of pharma, biologics, and dietary-supplement companies still touch: bovine-derived inputs, dairy-adjacent excipients, animal-sourced raw materials. A supplier with a residue violation like this one, or with treatment records too thin to establish a withdrawal period, becomes the weak link in a buyer's own adulteration exposure, not just its own.
FDA copied Minnesota's Department of Agriculture and its Office of Dairy and Seafood Safety on the letter, a detail that signals the agency isn't treating this as a federal-only matter. State agriculture and dairy-safety regulators got the same notice at the same time.
What happens next
Allandale Dairy has 15 working days from receipt of the letter to respond in writing, detailing corrective actions and a timeline for completing them. FDA states plainly that, as of the warning letter's date, it had not received a response to the Form FDA 483 issued at the close of the March inspection. Whether that response has since arrived isn't part of the public record reviewed here. As of this writing, no close-out letter has been posted for CMS #727610, and this piece won't speculate about the timeline or content of a remediation the record doesn't yet show.
FAQ
What triggered FDA's warning letter to Allandale Dairy?
FDA's Center for Veterinary Medicine inspected the Pierz, Minnesota dairy on March 3, 11, and 19, 2026, and combined that inspection with a USDA/FSIS tissue-sample test result showing sulfadimethoxine at 0.116 ppm in the liver of a cow the farm had sold for slaughter, above FDA's 0.1 ppm tolerance for cattle edible tissue under 21 CFR 556.640(b)(2)(i).
What are the two violations cited in the letter?
First, adulteration of an animal offered for human consumption under FD&C Act § 402(a)(2)(C)(ii) (21 U.S.C. § 342(a)(2)(C)(ii)), based on the residue reading plus incomplete treatment records that couldn't establish a proper drug-withdrawal period. Second, extralabel use of Sulfadimethoxine Injection 40% and a flunixin meglumine injection in a manner inconsistent with the products' labeling and the treating veterinarian's prescription, governed by 21 CFR Part 530 under AMDUCA.
Is extralabel drug use in dairy cattle always illegal?
No. AMDUCA and 21 CFR Part 530 permit extralabel use of an approved animal drug, but only by or on the lawful order of a veterinarian within a valid veterinarian-client-patient relationship, and only consistent with that veterinarian's specific order. FDA's letter states Allandale Dairy's actual dosing didn't match either the approved label or the prescribing veterinarian's order.
Has Allandale Dairy responded to the warning letter?
The letter states that, as of its June 23, 2026 date, FDA had not received a response to the Form FDA 483 issued after the March 2026 inspection. No public close-out letter has been posted for CMS #727610 as of this writing.
Source: FDA Warning Letter, CMS #727610, June 23, 2026. Byline: Andy Gaber, Founder. Published 2026-07-17.