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.
Little Sleepies is recalling approximately 450,000 Sleepyhead Loveys and Bandana Bibs because the care instruction label can detach, posing a choking hazard to young children.
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.
Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.
Dr. Berne's MSM DROPS 5% Solution is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 3833 bottles distributed nationwide and internationally.
Target's Good & Gather Organic Jasmine Rice is being recalled due to rice weevils found in bags. Consumers should not consume affected product.
Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.
Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
RB Health (US) is recalling Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%) due to an incorrect label on the back of the packaging. The recall affects 36,426 individual units distributed nationwide.
Moreflavor, Inc. recalled 44 one-pound bags of CellarScience ascorbic acid (batch 56559) due to labeling error: bags labeled as ascorbic acid contain sodium percarbonate.
Tolmar, Inc. is recalling Eligard (leuprolide acetate) 7.5 mg monthly injectable suspension nationwide because the constituted product contains higher than expected levels of the active ingredient. The affected lot is 13635A1 with expiration date July 31, 2024.
Vitality Works, Inc. is recalling its 100 Vegetarian Fenugreek Capsules due to contamination with pen pieces. The recall affects 1,025 bottles distributed to 284 retail stores across the United States.
Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.
Vitality Works, Inc. is recalling 100 vegetarian fenugreek capsules (600mg) because some bottles contain pen fragments. Approximately 1,025 bottles were distributed to retail stores across the United States.
Vitality Works is recalling 1,025 bottles of Fenugreek Capsules (Lot 2023-06871) due to contamination with pen pieces. The product was distributed to 284 retail stores across the United States.
Ozona Organics LLC is recalling Ozona Organics and Go Healthy Liquid Probiotics nationwide due to high water activity in the formula that could allow microbial growth. No illnesses have been reported.
Pharma-Natural Inc. is recalling Pharma Natural Biotin 5000 mcg dietary supplement (Lot PN10686, Exp. Date 01/24) distributed in Puerto Rico because FDA testing found the biotin content was below the detection limit.
Procter & Gamble is recalling Zevo Fly, Gnat and Fruit Fly Flying Insect Killer3 Value Packs because the aerosol containers can rupture and leak, posing injury and laceration hazards.
Rust-Oleum Professional Fluorescent Pink Inverted Marking Spray Paint cans are recalled because the spray valve assembly can detach with force, creating an impact injury hazard. The company has received five reports of detachment with paint splatter and no injuries reported.
Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.
Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.
Great Lakes Cheese is recalling multiple brands of refrigerated pasteurized cheese products due to conflicting refrigeration instructions on product labels. The conflicting label requirements could lead to improper storage.
Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.
Multiple cheese spread brands are being recalled due to inconsistent refrigeration instructions on labels. Consumers should verify proper storage and discard products with unclear label instructions.