The Food and Drug Administration issued a warning letter to Hill’s Pet Nutrition this past November following an investigation prompted by a recall of dog food products that contained toxic amounts of vitamin D.
The FDA issues a warning letter when it finds that a manufacturer has significantly violated agency regulations. The letter makes clear that the company must correct the problem and provides directions and a time frame for the company to inform FDA of its plans to correct any concerns.
The agency says Hill’s failed to follow company procedures for consistently verifying the quality of ingredients in its pet foods. Hill’s says it has already addressed the FDA’s concerns to avoid potential problems with its food ingredients in the future.
The FDA letter details the results of the agency’s investigation, which included inspections of the company’s Topeka, Kansas, manufacturing facility. The investigation was launched after Hill’s voluntarily recalled a total of 86 product lots, including 33 varieties of its canned dog food products. The recall started in January last year and eventually expanded to include additional products and product lots in the spring. The products were manufactured by Hill’s and marketed under the Hill’s Science Diet and Hill’s Prescription Diet brands. Overall, the recalls affected slightly more than 1 million cases of dog food, or nearly 22 million cans. No dry foods, cat foods, or treats were affected by the recall.
The FDA confirmed Hill’s findings that pet food products with unsafe levels of vitamin D were manufactured and marketed by the company. Further, the FDA confirmed that Hill’s had determined that the unsafe levels of vitamin D were a result of an ingredient that it received and accepted in the form of a vitamin premix from a supplier “in a manner not in accordance with your receiving procedures, and that was subsequently incorporated in the animal food products,” according to the letter.
Hill’s standard procedures required that raw materials such as the vitamin premix be analyzed and confirmed to be safe before being unloaded at the company’s manufacturing facility. However, the FDA investigation found that the vitamin premix had not been analyzed and that the final product had not been tested to determine that it met Hill’s specific formulation. Plus, Hill’s failed to obtain certificates of analysis from the supplier of the vitamin premix.
“As a result of your failure to follow your food safety plan, the hazard of vitamin D toxicity was not adequately managed at your receiving step,” the FDA wrote. “As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food.”
The vitamin D levels in tested lots of recalled products were more than 33 times the recommended safe upper limit.
In its letter, the FDA states that it cannot assess Hill’s corrective actions adequately since they don’t “address the root cause of this incident, which was accepting an ingredient without confirming that it contained vitamin levels that were within specification as required by your procedures.” The FDA says it will verify Hill’s proposed voluntary corrective actions—submitted in March, May, and August last year—during a future inspection.
“We care deeply about all pets and are committed to providing pet parents with safe and high-quality products. Hill’s has already addressed the matters raised by the FDA in its warning letter and has put in place stricter processes to safeguard against the cause of the recall from recurring, including testing every vitamin premix lot before it is delivered to us by a certified, third-party laboratory, with the results delivered directly to Hill’s for review by our quality and food safety experts. No vitamin premix is accepted at our plants without a Certificate of Analysis that confirms it has been properly formulated. We are committed to earning the trust of pet parents and to safeguarding the quality of our products.
Has Hill’s Prescription Diet Ever Been Recalled?
Yes. Hill’s Prescription Diet has had 2 recalls that we are aware of.
Most recently, in January 2019, Hill’s Pet Nutrition issued a massive, worldwide recall of 33 different varieties of its canned dog foods — 22 million cans recalled in all — because of toxic levels of Vitamin D, which Hill’s blamed on a “supplier error.”
The recall included both the Hill’s Prescription Diet and Hill’s Science Diet brand lines. However, no dry foods, cat foods or pet treats were included in the recall.
Reportedly hundreds of dogs died after eating the affected dog food.
The other Hill’s Prescription Diet recall was about a decade earlier, in April 2007. That is when a single dry cat food — Hill’s Prescription Diet m/d Feline — was recalled as part of the massive 2007 Menu Foods/melamine recalls. “It is our priority to help consumers understand that there is only one product in question: Hill’s Prescription Diet m/d Feline dry food,” the company said on its website.
Complete details of every Hill’s Prescription Diet recall appear below.
This next one was not a recall, but way back in August 1987, a study published in the journal Science drew attention to the fact that thousands of cats had been dying every year from a form of heart disease called dilated cardiomyopathy (DCM), because of an apparent taurine deficiency in popular cat foods at the time.
In the study, researchers observed cats who were diagnosed with DCM and had been fed popular commercial cat foods such as:
Taurine deficiencies observed in the cats seemed like too much of a coincidence. Clearly, cats needed more taurine than was being provided by the foods at the time.
By the time the groundbreaking Science article was published, pet food makers like Hill’s Pet Nutrition and Ralston Purina had already begun changing their recipes to include higher levels of taurine.
Again, no recall was ever issued, to our knowledge. However, the recipe reformulations brought about a dramatic decrease in the incidence of DCM in cats.
Next, we list the full details of every single Hill’s Prescription Diet recall.
Has Hill’s Science Diet Ever Been Recalled?
Yes. Hill’s Science Diet has been recalled a number of times in recent years.
Most recently, in January 2019, Hill’s Pet Nutrition issued a massive, worldwide recall of 33 different varieties of its canned dog foods — 22 million cans recalled in all — because of toxic levels of Vitamin D, which Hill’s blamed on a “supplier error.”
The recall included both the Hill’s Science Diet and Hill’s Prescription Diet brand lines. However, no dry foods, cat foods or pet treats were included in the recall.
Reportedly hundreds of dogs died after eating the affected dog food. Families who spoke with Petful told us their dogs had been in good health, but then, within a matter of days, their pets’ well-being took a severe downturn, ending in kidney problems, kidney failure and, in some cases, death.
“We believe that hundreds, if not thousands, of pets have died or become seriously ill as a result of eating Hill’s foods with toxic levels of Vitamin D,” attorney Nyran Rose Rasche told CBS News.
Following an investigation into that recall, the U.S. Food and Drug Administration (FDA) published a warning letter (archived here) stating that Hill’s had failed to follow its own procedures. “A systematic failure of your food safety plan occurred that resulted in the recall of canned dog food,” the FDA said.
The FDA ordered Hill’s to take corrective actions and put the company on notice of future inspections.
In response, Hill’s said, “We care deeply about all pets and are committed to providing pet parents with safe and high-quality products.… We continue to cooperate with the FDA, including all inspections and requests for information.”
A consolidated lawsuit with about 300 named plaintiffs is being overseen by the U.S. District Court in Kansas City. The case is called In Re: Hill’s Pet Nutrition Inc. Dog Food Products Liability Litigation, case number 2:19-md-02887.
For more on the 2019 Science Diet/Prescription Diet recall, be sure to read our article about how families were left horrified and heartbroken.
In November 2015, Hill’s initiated a market withdrawal (not a recall) of certain Hill’s Science Diet canned pet foods for unknown reasons. We learned about this via a note posted in some PetSmart retail locations.
One consumer who contacted a Hill’s customer service representative and asked about the reason for the market withdrawal was told they “don’t have that information” but that the products were “perfectly safe.”
Per the FDA definition, a market withdrawal is issued when there are minor problems with the products, such as a labeling mistake, as has been speculated in this case.
The year before that, in June 2014, 62 bags of Hill’s Science Diet Adult Small & Toy Breed dry dog food were recalled in California, Hawaii and Nevada because of potential salmonella contamination.
In March 2007, Hill’s Science Diet was one of more than 100 brands included in a wide-ranging recall of pet food that the FDA and other food safety officials determined may contain melamine — a chemical used in plastics manufacture. Every single can of Hill’s Science Diet Savory Cuts cat food was recalled. Thousands of pets died in the wake of the Menu Foods/melamine recalls.
Our research team spent hours going through recall databases and news archives to find earlier recalls of Hill’s Science Diet. We didn’t find any, but we did uncover another dark chapter in this pet food’s history.
Way back in August 1987, a study published in the journal Science drew attention to the fact that thousands of cats had been dying every year from DCM, the fatal heart condition, because of an apparent taurine deficiency in popular cat foods at the time.
In the study, Dr. Paul D. Pion, DVM, DACVIM, and others observed cats who were diagnosed with DCM and had been fed popular commercial cat foods such as:
Taurine deficiencies observed in the cats seemed like too much of a coincidence. Clearly, cats needed more taurine than was being provided by the foods at the time.
By the time the groundbreaking Science article was published, pet food makers like Hill’s Pet Nutrition and Ralston Purina had already begun changing their recipes to include higher levels of taurine.
No recall was ever issued, to our knowledge. However, the recipe reformulations brought about a dramatic decrease in the incidence of DCM in cats. A 1990 follow-up study using data from 2 veterinary hospitals found DCM in only 6% of cat patients, versus 28% of cats brought into the hospitals before the recipe changes went into effect.
Speaking at a 2019 “Science of Cats” summit, Dr. Pion shared that during the lead-up to publication in Science, he and his fellow researchers had faced “legal and other manipulations and threats from pet food companies trying to distance themselves.”
An executive from Hill’s Pet Nutrition, he recalled, “took the aggressive stance that this couldn’t be related to their diets and suggested, with impolite words, that our group was foolish and irresponsible for pursuing these investigations.”
And then, Dr. Pion added, “As other pet food companies were similarly implicated, we began receiving letters from their lawyers.”
On the positive side, he said, “I am glad that after this and other incidents, including the melamine pet food incident of 2007, our colleagues at pet food companies have often opted to take a more collaborative and open-minded approach when veterinarians suggest there may be a problem related to diets.”
Below, we list the full details of every single Hill’s Science Diet recall.
The agency says Hill’s failed to follow company procedures for consistently verifying the quality of ingredients in its pet foods. Hill’s says it has already addressed the FDA’s concerns to avoid potential problems with its food ingredients in the future.
“As a result of your failure to follow your food safety plan, the hazard of vitamin D toxicity was not adequately managed at your receiving step,” the FDA wrote. “As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food.”
The Food and Drug Administration issued a warning letter to Hill’s Pet Nutrition this past November following an investigation prompted by a recall of dog food products that contained toxic amounts of vitamin D.
The FDA confirmed Hill’s findings that pet food products with unsafe levels of vitamin D were manufactured and marketed by the company. Further, the FDA confirmed that Hill’s had determined that the unsafe levels of vitamin D were a result of an ingredient that it received and accepted in the form of a vitamin premix from a supplier “in a manner not in accordance with your receiving procedures, and that was subsequently incorporated in the animal food products,” according to the letter.
Hill’s standard procedures required that raw materials such as the vitamin premix be analyzed and confirmed to be safe before being unloaded at the company’s manufacturing facility. However, the FDA investigation found that the vitamin premix had not been analyzed and that the final product had not been tested to determine that it met Hill’s specific formulation. Plus, Hill’s failed to obtain certificates of analysis from the supplier of the vitamin premix.
FAQ
How many times has Hills Science Diet been recalled?
Has Hill’s Science Diet ever had a recall?
Which Hill’s dog food has been recalled?
Did Hills Prescription Diet change their formula?