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.
CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.
CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.
CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct instructions.
Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.
BayCare Central Pharmacy is recalling 1,157 bags of norepinephrine bitartrate 16 mg in 250 mL saline solution distributed in Florida because the drug is subpotent—meaning it contains less active ingredient than labeled.
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling. The recall affects 6,430 cartons distributed throughout the USA.
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling on certain cartons. The recall affects 218,174 cartons distributed in the United States.
Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).
CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.
Dr. Reddy's Laboratories is recalling Wal-Fex D Extended Release Tablets nationwide due to failed dissolution specifications. The affected product combines fexofenadine (antihistamine) and pseudoephedrine (decongestant).
Rite Aid Pharmacy is recalling Allergy & Congestion extended-release tablets because two lots failed to meet dissolution specifications. The affected product was distributed nationwide.
Dr. Reddy's Laboratories is recalling Mucus Relief D (Guaifenesin Pseudoephedrine HCl ER Tablets) nationwide due to subpotency. The affected product was distributed to Walgreen Co. stores across the USA.
Aroma Meats LLC has recalled Fish-Pickle packaged in yellow plastic pouches distributed in Oregon because the specific type of fish used is not declared on the label, contrary to regulatory requirements.
Dr. Reddy's Laboratories is recalling Rugby brand antihistamine and nasal decongestant tablets nationwide due to failed dissolution specifications. The affected product is NDC 0536-1242-07, Lot #AC2106452F with expiration date 3/31/2023.
The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.
Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.
Morton Iodized Salt labeled as iodized actually contains salt without iodine fortification. The recall affects 16,920 canisters distributed to retailers in Colorado and California.
The Mustard Man Inc is recalling Simply Peppered Mustard bottles that were incorrectly filled with Simply Horsey Mustard instead. The product was distributed in eight states and should not be consumed.
Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.
CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.
Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.
Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.