Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Wilton Brands is voluntarily recalling 15,032 units of Chocolate Decorator Icing due to mold. The product was distributed in 35 states.
Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.
Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.
Cardiocommand Inc. is recalling six TAPSYSTEM Model 2A units due to a potential assembly error where the battery wire may be incorrectly connected to the power switch.
Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.
Reily Foods is recalling Blue Plate Light Mayonnaise because yeast caused gas formation, leading to bloated bottles and product leakage.
Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.
Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.
Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.
Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.
Tate & Lyle is recalling specific lots of Miraqk Mgl and Nustar food starch because a screen failure may have allowed small pieces of wire to enter the product.
Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets because testing showed aluminum elution during fluid warming.
Yamaha is recalling about 1,500 Grizzly ATVs and Wolverine X2 ROVs because the owner's manuals contain information for the wrong models.
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurities and degradation specifications.
Akorn Inc. is recalling 16,216 cartons of Myorisan isotretinoin capsules because secondary cartons incorrectly state 40 mg instead of 30 mg.
Arrow International Inc. is recalling 12 units of JACC central catheters because the expiration date printed on the packaging is incorrect.
Arrow International Inc. is recalling 3 units of Arrow JACC with Chloragard Technology due to an incorrect expiration date.
Cytocell Ltd. is recalling Aquarius D13S319 Plus Deletion Probes because the chromomap on the package insert contains an error.
Arrow International Inc. is recalling 6 units of Arrow JACC Central Catheters because the expiration date is incorrect.
Microbiologics Inc is recalling 22 units of the Cepheid Xpert C. difficile/Epi Control Panel because the expiration date is incorrectly labeled as 2021-10-31 instead of 2021-03-31.
Arrow International Inc is recalling 16 units of Arrowg+ard Blue Advance JACC because the product has an incorrect expiration date.
Fresenius Kabi USA, LLC is recalling 11,981 vials of Ondansetron Injection, USP, 40 mg / 20 mL, because the product failed impurities and degradation specifications.
Laird Superfood is recalling Performance Mushrooms because the label incorrectly lists 14 mg of Iron instead of the actual 14 mcg.
Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.
Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on software version 2.72.