A commonly used heartburn medication has been recalled due to discoloration, according to a notice that was recently published by the Food and Drug Administration (FDA).
The notice, which was uploaded on the agency’s website last week, said that Hetero Labs Limited of India recalled one batch of pantoprazole sodium in March. The FDA classified the recall on April 17.
The company said it received five discoloration complaints indicating that the “tablets discolored darker than normal and have lighter-colored spots,” the notice said. The recall was done voluntarily and is still ongoing, it added.
The recall impacts 4,750 1,000-count, prescription-only bottles of pantoprazole sodium delayed-release tablets in 40-milligram strength. The affected bottles have an expiration date of June 26, 2027, and a batch number of FD253967.
The product was manufactured by Hetero Labs Limited for Camber Pharmaceuticals Inc., of New Jersey, according to the FDA.
A statement was not issued for the recall, and there were no other details provided about the action.
The recall was deemed by the FDA as Class II, which the agency describes on its website as a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” It’s the second-highest classification out three, with Class I being the most severe.
Pantoprazole sodium belongs to a category of medications known as proton pump inhibitors (PPIs), which are used to lower stomach acidy to treat acid reflux, stomach ulcers, heartburn, and gastroesophageal reflux disease (GERD).
Pantoprazole sodium among the most commonly prescribed drugs in the United States. Medication database ClincCalc says more than 37 million prescriptions were filled and 9 million people were prescribed the drug in 2023, making it the 13th most commonly taken drug for that year.
The FDA sent a warning letter to Hetero Labs Limited in 2017 after inspectors found “significant violations” at one of its manufacturing plants in India, writing that it “failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.”
In 2022, the agency said it completed an evaluation and found that Hetero Labs appeared to have addressed violations that were discovered by the FDA.
However, following an inspection in September 2025 at a warehouse storing pharmaceutical ingredients, the FDA sent a letter to the company stating that the officials found pest infestations such as birds, lizards, and cats, along with findings of bird fecal matter on containers as well as nests within the facilities.