US FDA

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin

Alembic Pharmaceuticals Limited Units I & II – 05/26-31/2025. Country: India. Record Type: 483

Learn more about FDA’s Postmarketing Requirements and Commitments Searchable Database.

FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

October 28, 2025, Vanguard Enterprises, LLC. DBA Bedrock MFG of Boise, Idaho is recalling Monarch Premium Kratom brand Bali Gold, Red Bali, Green Maeng Da, and White Elephant powder because product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometime

October 29, 2025 – Moonlight Companies is voluntarily recalling California-grown conventional yellow and white peaches because they have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly

Zydus Lifesciences Limited – 08/13/2025. Country: India. Record Type: 483

Joint US FDA – Health Canada ICH Public Meeting

drug recalls page, FDA’s role

Concord Biotech Limited – 04/28/2025-05/02/2025. Country: India. Record Type: 483