Warning letters, recalls, import alerts and other FDA enforcement actions affecting pharmacies, compounders and related businesses.
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Every new official record on the Pharmacy, Compounding & Regulatory Intelligence desk since this morning, each linked to its primary source.
Automated from official records6 sources1 min read
For generations, families have trusted Mezzetta products on their tables. We take that trust seriously, which is why we want to share what we know about a voluntary recall involving a specific lot of Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT, 32-ounce, and the actions that…
Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal…
The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.
ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellu…
Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd.
Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially conta…
