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.
Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.
Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.
Synthetopes Inc. is recalling Sn-Pyrophosphate Kits because of a lack of processing controls. The recall covers all lots remaining within their expiry dates.
Luminex Molecular Diagnostics is recalling 965 xTAG Gastrointestinal Pathogen Panel kits due to reports of lower MS2 MFI values.
B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.
Wismettac Asian Foods is recalling Meiji Black Chocolate bars because they lack English labels for nutrition facts, ingredients, and allergens.
Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.
Cardiocommand Inc. is recalling five units of its Transesophageal Cardiac Pacing and Recording System, Model 7A, due to possible corrosion of the battery contacts.
Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.
Wismettac Asian Foods is recalling Meiji Chocolate Choco Baby bars because they lack English labels for nutrition facts, ingredients, and allergens.
Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.
Synthetopes Inc. is recalling Sulfur Colloid Reaction Vials nationwide due to a lack of processing controls.
Wismettac Asian Foods is recalling Meiji Chocolate Almond bars because they lack English labels for ingredients and allergens, including milk, soy, egg, and tree nuts.
Chiesi USA is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, because they failed dissolution specifications.
Geritrex, LLC is recalling 1,536 bottles of Senna Syrup due to reports of atypical odor and unpleasant taste.
Baxter Healthcare is recalling 5,940 bottles of Sevoflurane inhalation anesthetic because the product failed stability specifications.
GE Healthcare is recalling Prestige II, SI, and VH systems because a CRT monitor fell off its wall mount due to product aging.
Wismettac Asian Foods is recalling Meiji Chocolate Milk Chocolate bars because they lack English labels for ingredients and allergens, including milk, soy, egg, and tree nuts.
Geritrex, LLC is recalling Senna Syrup bottles due to reports of atypical odor and unpleasant taste.
Philips is recalling Patient Information Center iX software because infusion pump data may be recorded at 100 times the actual rate.
Philips is recalling IntelliBridge Systems configured with comma decimal separators because infusion pump data may be recorded at 100 times the actual values.
Synthetopes Inc is recalling Sn-Mertiatide Kits nationwide due to a lack of processing controls. The recall covers all lots remaining within their expiry date.
GE Healthcare is recalling Precision 500D X-ray systems because a CRT monitor fell off its wall mount due to product aging.
Conformis is recalling 183 iTotal Hip Replacement System stems nationwide due to a 3mm discrepancy between approved and manufactured neck/head lengths.
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the plunger delivery system is not functioning properly.