All articles tagged with #fda
The FDA issued a Class II recall of about 2.5 million bottles of prednisolone acetate ophthalmic suspension 1% eye drops by Lupin Pharmaceuticals due to a potential foreign-substance contamination. The products—available in 5 mL, 10 mL, and 15 mL sizes—were initially recalled on June 4 and reclassified on June 30; the drops treat non-infectious eye allergies and inflammation.
The FDA has recalled more than 2.5 million bottles of Lupin's prednisolone acetate eye drops due to a possible foreign substance; the substance and its entry method aren’t identified. The affected bottles (5 mL, 10 mL, 15 mL) are from India-based Lupin and are used to reduce inflammation after eye surgery or for allergies. Because this is a Class II recall (high risk), patients should not stop using the product on their own and should consult an eye doctor or pharmacist for guidance based on their condition.
Lupin Pharmaceuticals is recalling more than 2.5 million prednisolone acetate eye drops in the U.S. due to a foreign substance; manufactured in India and sold in 5 mL, 10 mL, and 15 mL bottles with expiry dates from July 31, 2026 to March 31, 2028; the FDA class II recall indicates potential temporary health effects, though no injuries have been reported; Lupin did not immediately respond to questions, and the recall began in early June.
The FDA reports that trace amounts of metals found in tampons do not pose health risks to women, addressing earlier concerns about absorption. The agency’s lab study concluded metals such as arsenic and lead found in these products aren’t harmful in the amounts detected during typical use.
The FDA rejected a petition by the Tucson Environmental Justice Task Force to set formal PFAS limits in food, instead proposing non-binding action levels and indicating it will pursue standards later. The group plans to sue, arguing that if PFAS are regulated in water they should be limited in food. Independent testing has found PFAS in seafood and milk, as well as in various foods and packaging, underscoring ongoing exposure concerns. PFAS are a broad class of persistent chemicals linked to cancer and other health issues, and critics say the FDA’s testing and regulatory approach remains insufficient to protect consumers.
Kao USA is recalling Oribe Serene Scalp Densifying Shampoo sold nationwide after the FDA detected Pluralibacter gergoviae; the affected products (8.5 oz and 33.8 oz) were manufactured Feb 21–26 in lots starting with YR. While the bacteria pose little risk to healthy people, those with weakened immune systems may be more vulnerable. Consumers should contact Kao’s Professional Hair Hotline at 800-333-2442 or [email protected] for a replacement.
A wellness-driven surge in peptide injections touted for healing, recovery, and muscle-building rests on limited clinical evidence and carries safety risks. In 2023 the FDA banned production of several peptides by compounding pharmacies due to safety concerns and impurities, and the agency does not approve such compounds. US policy discussions about legalizing broader compounding could boost access but also risk, as product quality and dosing vary and most data come from animal studies. Experts urge caution and emphasize that rigorous human trials are still needed to establish true benefits and safety.
The FDA has elevated Utz Quality Foods' recall of Zapp’s and Dirty potato chips to Class 1, its highest risk level, after a seasoning containing dry milk powder may be contaminated with Salmonella. The issue, tied to a supplier from California Dairies, Inc., prompted recalls announced April 28 and affects a limited number of products; no illnesses have been reported. Consumers should discard affected products and contact Utz for refunds; other Utz items are unaffected.
The FDA has classified Utz’s Dirty and Zapp’s potato chips as a Class 1 recall—the most serious—due to Salmonella linked to dried milk powder used in seasonings from California Dairies; the recall began in April/May 2026 with no reported illnesses, but the FDA warns exposure could cause serious health consequences, advising consumers to discard recalled products and contact Utz for questions, with specific best-by dates and product variants listed.
FDA upgraded Utz’s recall of Zapp’s and Dirty potato chips to Class 1 due to possible salmonella contamination from a dry milk powder seasoning ingredient; about 650,000 bags with best-by dates from late July to late August are affected. Utz reports no illnesses and urges consumers to discard the products and seek refunds; the agency has not provided further details on the consumer risk.
The FDA has issued a Class I recall—the highest risk level—for more than 650,000 bags of Zapp’s and Dirty-brand potato chips after a seasoning containing dry milk powder potentially contaminated with salmonella was used; Utz reports no illnesses and is offering refunds, while retailers have removed affected products from shelves. Consumers should discard recalled chips, check best-by dates and batch codes, and contact Utz for refunds as part of a broader investigation into the ingredient.
New York is among 17 states reporting cyclosporiasis infections linked to a multistate outbreak; the CDC says at least 145 illnesses nationwide since May 1, with 20 hospitalizations and no deaths. Most patients hadn’t traveled before symptoms, and federal agencies (CDC and FDA) are tracing the source of the Cyclospora parasite.
The FDA has upgraded the recall of certain Zapp's and Dirty Brand potato chips to Class I, the highest risk level, due to possible salmonella contamination; initially announced by Utz Quality Foods in May, the affected products span several flavors and sizes, and consumers should discard them and not eat them.
The FDA said it would allow Philip Morris to market Zyn nicotine pouches as a lower-risk alternative to cigarettes, approving 20 variants with claims that using Zyn reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. Regulators see potential population-health benefits, while scientists caution about risks to new users and youth. Philip Morris has been expanding Zyn sales and has lobbied for clearer, faster FDA approvals.
The FDA authorized 20 ZYN nicotine pouch products (in 3 mg and 6 mg strengths) to be marketed as lower risk than cigarettes, though not as a quit-smoking aid. The approval requires five years of post-market studies on risk perception and youth uptake, with the possibility of reversal if youth use rises. Experts warn nicotine addiction remains a concern and that many users may not fully switch from smoking, even as some flavors appeal to younger people.