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.
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.
CB Distribution LLC is recalling Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice packages due to incorrect ingredient labeling. The product was distributed to distribution centers in Texas.
Magnolia Vegetable Processors is recalling Wickles Relish 16oz glass jars (Lot No. 2001210406) due to an incorrect label applied to the product. The affected cases were distributed to eight states.
LNK International is recalling Acetaminophen Extra Strength coated tablets because the primary label incorrectly states "enteric coated" when the tablets are not enteric coated and should be labeled as standard coated tablets.
Bountiful Trading Inc is recalling Kroger brand Vitamin D3 125 mcg softgels because they may contain undeclared Coq10. Consumers with allergies or sensitivities to Coq10 are at risk.
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.
Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement (100 caplets, UPC 05380930801, Lot #30636, Exp. 01/2022) due to the presence of damaged tablets resulting from manufacturing deviations.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement 2-caplet bottles (Lot #30637, expiration 01.2022) due to the presence of damaged tablets resulting from Current Good Manufacturing Practice (CGMP) deviations.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.
MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.
Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.
Ascend Laboratories LLC is recalling 34,296 bottles of Olmesartan Medoxomil 20 mg tablets because they may contain a foreign tablet or capsule.
Dole is recalling 2,120 cases of Yellow cling Peach Slices because the lid label incorrectly identifies the contents as Mixed Fruit.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets due to the presence of degradation impurities.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement caplets due to the presence of damaged tablets, a Current Good Manufacturing Practice (CGMP) deviation.
Lopez Gonzalez Santana Corporation is recalling 662 bottles of BTREX PLUS dietary supplement because of damaged tablets. The product was distributed in Puerto Rico.
SigmaPharm Laboratories is recalling Asenapine sublingual tablets because they were manufactured with the wrong flavoring agent.
Nomax Inc. is voluntarily recalling 78 cartons of Dry Eye Test strips due to subpotent drug content. The FDA classified this as a Class III recall.
SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets because they were manufactured with the incorrect flavoring agent.
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplements due to damaged tablets, a cGMP deviation.