Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water…
Imu-Tek Animal Health, Incorporated recalled this product and the FDA reported the enforcement action on 8 April 2026 as Class II. The recall was initiated by the firm. Product is potentially under-processed.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.
- Reason for recall
- Product is potentially under-processed.
- Recalling firm
- Imu-Tek Animal Health, Incorporated
- Firm location
- Fort Collins, Colorado, United States
- Classification
- Class II
- Status
- Completed
- Recall number
- H-0661-2026
- Quantity
- 64 bottles
- Distribution
- Product distributed in the following states: AK, AL, AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MA, MD, MO, MS, NC, NE, NH, NV, NY, OK, OR, SC, TN, TX, UT, WA, WI, WY.
- Initiated
- 24 February 2026
- Reported by FDA
- 8 April 2026
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot #22, 020528 Expiration
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 2 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- This recall has no termination date on the record, so as published it had not been terminated under 21 CFR 7.55.
- The distribution pattern names 29 states, and the FDA published the enforcement report 6 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Named in the distribution pattern: Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, Nevada, New York, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin, Wyoming. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Process deviation
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 114
- Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2026-04-08 | Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524. | Imu-Tek Animal Health, Incorporated | Product is potentially under-processed. | Class II |
Other records from Imu-Tek Animal Health, Incorporated
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 3 records for Imu-Tek Animal Health, Incorporated
All 2026 recalls · All FDA food recall data
21 CFR 113 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.