Recalls and safety alerts from the FDA, newest first.
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement — Fairhope Roasting Company · Class II · Terminated · 15 gallons
Products were made with recalled California Dairies milk powder due to Salmonella. — Jonco Industries · Class I · Terminated · 1407 jars total
Potential for Salmonella — International Food Products Corporation · Class II · Ongoing · 20 bags
Undeclared Allergen (Soy) — Nutrisystem Inc · Class II · Ongoing · 5,184 units
The World Health Organization (WHO) today calls on countries to expand newborn screening for birth defects, highlighting how early detection and treatment can save lives and reduce lifelong disability for millions of children. A new WHO report, Strengthening capacity for newborn screening, diagnosis and management of birth defects , identifies newborn screening as an important opportunity to accelerate progress in child survival. Many conditions can be successfully treated if identified early after birth. These include congenital hypothyroidism, sickle-cell disease, hearing impairment and some…
A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
The air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
CHICAGO, June 18, 2026 – MORNINGSTAR FARMS is voluntarily recalling two varieties of products in the U.S., Puerto Rico and Costa Rica because of possible plastic pieces in the food. Recalled varieties are: MORNINGSTAR FARMS Buffalo Chik’n Nuggets (10.5 oz) and MORNINGSTAR FARMS Hot & Spicy Sausage
June 18, 2026 - Clover Hill Dairy of Mechanicsville, Maryland is expanding their recall to include all Clover Hill Dairy brand cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, f
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis
Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis — Ascend Laboratories, LLC · Class II · Ongoing · 360 30-count bottles
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. — Haleon US Holdings LLC · Class I · Ongoing · 35,883 boxes/carton
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing · N/A
Microbial contamination of sterile products — Zep Inc · Class II · Ongoing · 5 drums
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Breckenridge Pharmaceutical, Inc. · Class II · Ongoing · 359,676 bottles
Failed Impurities/Degradations Specifications — Fresenius Kabi USA, LLC · Class III · Ongoing · 898,050 vials
Presence of Particulate matter: Particulate matter identified as glass. — SUN PHARMACEUTICAL INDUSTRIES INC · Class I · Ongoing · 675 vials
Microbial Contamination of Non-Sterile Products — BEEKEEPER'S NATURALS USA INC. · Not Yet Classified · Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Breckenridge Pharmaceutical, Inc. · Class II · Ongoing · 14,729 bottles
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. — Amneal Pharmaceuticals, LLC · Class III · Ongoing · 27,936 100-count bottles
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. — Golden State Medical Supply Inc. · Class II · Ongoing · 2,961 bottles
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. — INSPIREMD Inc · Class II · Ongoing
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. — GE Medical Systems, LLC · Class II · Ongoing