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.
Fresenius Kabi USA is recalling 93,000 vials of Hydralazine Hydrochloride Injection because the expiration date printed on the secondary packaging is incorrect.
Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17 mg, because they failed to meet dissolution specifications. The recall covers products distributed nationwide and in Puerto Rico.
Perrigo Israel Pharmaceuticals is voluntarily recalling 158,268 tubes of Mometasone Furoate Ointment USP, 0.1%, because the product is subpotent.
Actavis is recalling 11,445 bottles of Desmopressin Acetate Tablets because some tablets are incorrectly imprinted with an X.
GlaxoSmithKline is recalling Panadol Extra Strength acetaminophen bottles in Puerto Rico and the Virgin Islands because the product failed dissolution specifications.
Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.
Acon Laboratories is recalling 1,283 Mission Breath Alcohol Detector kits due to a labeling amendment. The devices are distributed nationwide.
Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.
Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.
EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.
Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.
Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.
Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.
American Health Packaging is recalling Desmopressin Acetate Tablets because some are incorrectly imprinted with an X on one side.
Tosoh Bioscience is recalling G7 Variant Elution Buffer HiS no. 1 (M) because it is labeled with an expiration date of October 2015 instead of the correct October 2014.
BD Biosciences is recalling 2,188 flow cytometers installed between June 2007 and September 2011 because they lack required FDA laser safety labeling.
Geritrex Corp is recalling Carb-O-Philic 40 Cream due to a CGMP deviation involving poor container closure of the bulk storage container.
Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride 25 mg tablets because some identification codes are unreadable.
Huxtables Kitchen is recalling approximately 778 pounds of Trader Joe's salad products because they may contain undeclared nitrites in the bacon.
The Sausage Factory Inc. is recalling approximately 5,960 pounds of sausage products because some packages may not bear the required USDA mark of inspection.
Abrams Royal Pharmacy II is recalling CORTISOL-MC 10mg capsules because they failed uniformity of dosage unit specifications.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels display incorrect expiration dates.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because they have incorrect expiration dates on the primary labeling.
Volk Optical Inc is recalling 78 units of the Lombart 90D Clear lens due to an incorrect lot number engraved on the aluminum ring.
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.