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.
Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution (4% / 0.05%, 240mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Beaverton Foods Inc is recalling Beaver Brand Tartar Sauce with Fresh Capers and Dill because soybean oil, a soy derivative, is not declared in the ingredients statement. This product may pose a risk to consumers with soy allergies.
Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.
American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.
Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.
Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg nationwide because the tablets failed to meet dissolution specifications, which may affect how the medication releases in the body.
Edge Pharma, LLC is recalling Edetate Disodium (EDTA) 1.5% Sterile Ophthalmic Solution nationwide due to lack of assurance of sterility. The recalled product is a single-dose eye drop solution.
CariFree sample boxes containing CTx4 Gel 5000 are being recalled because the product contains less Sodium Fluoride than stated on the label. Affected lots are 492106 and 492107, distributed nationwide.
The FDA is recalling CTx7 Kits distributed nationwide because the product contains less sodium fluoride than stated on the label.
Dental Alliance Holdings LLC is recalling the CTx36 Kit because it contains less sodium fluoride than stated on the product label. Affected patients should contact their dentist.
GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.
Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.
Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.
GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.
Edge Pharma, LLC is recalling Trypan Blue 0.03% ophthalmic solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on December 6, 2021.
Aroma Meats LLC is recalling Curry Leaf Powder (Karevepaku Podi) 1/4 KG packages distributed in Oregon because the product was sourced from an unapproved supplier.
Aroma Meats LLC is recalling Jackfruit Mango Pickle (Fresh Panasapottu) distributed in Oregon because the product was sourced from an unapproved supplier.
Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.
Aroma Meats LLC is recalling Daliya Split Powder (Putnala Podi) distributed in Oregon because the product was sourced from an unapproved supplier. Consumers should not use this product.
Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.
Aroma Meats LLC is recalling Fresh Banana Pickle packaged in 500 gm clear plastic pouches because the product was sourced from an unapproved supplier. The product was distributed in Oregon.
Aroma Meats LLC is recalling Ginger Pickle (Fresh Allam Avakai) packaged in 500-gram white plastic pouches distributed in Oregon because the product was from an unapproved source.