Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Genentech is recalling two lots of Xolair (omalizumab) injection nationwide due to out-of-specification Polysorbate 20 content detected at the 12-month stability testing timepoint. The affected lots are 3352758 and 3352759, both with August 2021 expiration dates.
Academy Sports + Outdoors is recalling about 3,860 Ozone 500 Girls' and Boys' Elevate 24-Inch Bicycles because the rear shock spring can become stuck, creating a pinch point and posing a fall hazard to riders.
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.
Heritage Family Specialty Foods is recalling Taco Casa Green Salsa due to potential foreign material contamination. The affected product was distributed nationwide.
ECHO EGi-2300 Watt Generators can overheat and catch fire, posing a fire and burn hazard. The manufacturer has received four reports of overheating or fire, though no injuries have been reported.
HoYu (US) Logistics Inc is recalling QiYu Hand Sanitizer (75% ethyl alcohol) because the product is subpotent. The recall affects 30,880 bottles distributed nationwide.
El Presidente Foods is recalling Just Nuts Japanese Style Peanuts (6.17 oz bags, Lot 317-20, expiring July 19, 2021) distributed in California because FDA inspection found the peanuts contained non-approved Red #6 dye.
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.
Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.
Rejuvenation is recalling about 3,325 Deep Frame Mirrors because the adhesive securing the mirror glass can fail, causing the glass to detach and fall out of the frame. Rejuvenation has received 18 reports of glass detaching, though no injuries have been reported.
Teligent Pharma is recalling Diflorasone Diacetate Ointment USP 0.05% due to the presence of foreign particles found during routine stability testing. The recall affects 6,240 tubes distributed nationwide.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Caramel Cashew Trail Mix nationwide because the product may contain stringy pieces of flexible plastic.
Cardinal Health is recalling Vicks 1.5-gallon vaporizers exposed to temperature excursions during shipping delays in February-March 2021, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.
SAN Corporation is recalling Tight! Xtreme Reloaded dietary supplement capsules because FDA inspection found an unapproved New Dietary Ingredient, Hordenine, in the product.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Peanut Butter Chocolate Trail Mix because some packages may contain stringy pieces of flexible plastic.
Larsen's Creamery, Inc. is recalling Bulk Salted Butter, item #502, due to an out-of-compliance HTST (High Temperature Short Time) recording chart. The recalled butter was made from pasteurized milk on 4/7/21 and distributed in Oregon and Washington.
Medical Action Industries is recalling Mosquito Hemostats due to potential flaking metal and brown spots on the devices. The recall affects 23 boxes of surgical instruments distributed nationwide.
Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Pacific Meridian Group is recalling Ful-Flav-R Green Pace Chili Diced due to reports of plastic pieces found in the product. The affected items were distributed in Texas.
Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.
Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Exact Medical Manufacturing is recalling 17,545 units of a 6" x 48" Elastic Poly Probe Cover that lacks FDA 510(k) clearance for use in body openings. The product should not be used without proper FDA pre-market approval.
Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Inlightened Partners LLC is recalling 926 inLight Medical LED Pads due to improper assembly of cord connectors, which may cause power interruptions and controller shutdown.