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.
Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.
Advantice Health is recalling Dermoplast Anesthetic Spray canisters because the label incorrectly states the net weight as 2.75 oz instead of 2.0 oz.
Carolina Liquid Chemistries is recalling 14 Etha RGT. Kits (Lot 11686) due to quality concerns. The recall is voluntary and has been terminated.
Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.
Lupin Pharmaceuticals is recalling 17,328 bottles of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.
Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because it failed impurity specifications during stability testing.
Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.
Zydus Pharmaceuticals is recalling Carvedilol tablets 3.125 mg because a customer complaint identified a fragmented tablet of another drug product mixed in the bottle.
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
Johnson Matthey Inc. is recalling Remifentanil HCl active pharmaceutical ingredient (API) because an unknown impurity exceeded specification limits.
Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.
Estee Lauder Inc is recalling 14,490 jars of Repairwear Laser Focus Line Smoothing Cream SPF 15 because the seal between the cap and jar is ineffective.
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1 because incorrect versions of the Instructions for Use were packaged into specific lots.
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2 because incorrect Instructions for Use were packaged with the product.
AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.
Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.
Auro Pharmacies Inc. is recalling 167 vials of Biotin 10 mg/mL Injection because the product failed to meet its pH label claim.
Medi-Physics Inc. dba GE Healthcare is recalling Thallous Chloride TI 201 Injection vials because trace amounts of an impurity were detected in the manufacturing reagent.
Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurity levels were detected at the 24-month time point.
Beaver Visitec is recalling 97 boxes of Micro Knife 5.0mm 30° instruments because the expiration date was misprinted as the lot number.
Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.