Fresenius Kabi USA recalls 898,050 vials of Epinephrine Injection due to failed impurities/degradation specifications in a Class III recall affecting nationwide US distribution.
Breckenridge Pharmaceutical recalls 359,676 bottles of Duloxetine Delayed-Release Capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA limits.
Zep Alcohol Sanitizer Spray 70% ethanol is subject to a Class II recall due to microbial contamination affecting 5 drums distributed nationwide; may cause temporary or reversible health problems.
Haleon US Holdings LLC recalls 35,883 boxes of Gas-X Extra Strength Simethicone nationwide due to propylene glycol coolant contamination from packaging machinery; Class I recall issued.
FDA corrects withdrawal of approval for 11 abbreviated new drug applications; Masuu Global Solutions LLC's propranolol and lidocaine ANDAs remain approved as of March 23, 2026.
Western Mixers Produce & Nuts recalls 9 oz. First Street brand Dark Chocolate Raisins due to undeclared peanuts posing serious risk to allergic consumers.
FDA amends regulations to direct the public to its website for organizational and contact information while revoking outdated regulations related to agency structure and contacts.
FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
Nara Organics recalls all lots of powdered infant formula nationwide due to potential Clostridium botulinum contamination posing risk of infant botulism.
Fry Pie Factory voluntarily recalls 5-ounce Pepperoni Rolls due to undeclared milk allergen and refrigeration process deviation as of June 12, 2026.
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