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.
ConvaTec recalls DuoDERM Control Gel Formula Border Dressings due to incorrect primary packaging labeling. Lot 8G03458 (expiring July 2023) was distributed in the US and Canada.
Borinquen Cones of Puerto Rico is recalling Crunchy Cones Mix Choco-Vanilla because the product label does not declare the presence of sulfites, which may pose a risk to consumers with sulfite sensitivity.
Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.
Washington Homeopathic Products is recalling ZTE 1013 Formula Antimicrobial (1000 ml, Lot # 25738) distributed nationwide because testing identified out-of-specification results during identification analysis.
Washington Homeopathic Products is recalling Cedar Fever Drops due to out-of-specification test results from identification testing. The affected product was distributed nationwide.
Olympus Corporation issued updated reprocessing instructions for the BF-XP60 bronchofiberscope to align with FDA 2015 guidance on medical device reprocessing validation and labeling.
Washington Homeopathic Products is recalling Althaea Officinalis 6X Irritable Bladder Sucrose/Lactose Pills distributed nationwide because test results failed to confirm the product's identity using HPTLC analysis.
Washington Homeopathic Products, Inc. is recalling ZTE-1020 Formula (1000ml bottle, Lot #25740) distributed nationwide because identification testing based on HPTLC analysis produced out-of-specification results.
Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 70 (5.0 oz aerosol cans) due to cGMP manufacturing deviations. The product was distributed nationwide.
Olympus Corporation is recalling 431 BF-Q180-AC EVIS EXERA II Bronchovideoscopes to issue validated reprocessing instructions aligned with FDA 2015 guidance.
Washington Homeopathic Products is recalling Cistus Canadensis 5X Coldness 20% Alcohol drops (15ml and 50ml bottles) distributed nationwide due to out-of-specification identification test results.
Washington Homeopathic Products is recalling Viola od 6X and 30X homeopathic pills (Lot #29057) distributed nationwide due to out-of-specification results in identity testing using HPTLC analysis.
Washington Homeopathic Products is recalling Cistus Canadensis homeopathic pills in multiple potencies because they failed out-of-specification identification testing. The recall affects 17 bottles distributed nationwide.
Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder drops (Lot #29377) distributed nationwide because identification testing via HPTLC analysis produced out-of-specification results.
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T60 bronchofiberscope to comply with FDA 2015 guidance on device reprocessing in health care settings.
Monarch PCM, LLC is recalling Ferretts IPS Iron Liquid Dietary Supplement because stability testing shows the product degraded to 81% potency over a 3-month period, falling below specification limits.
Olympus Corporation is issuing updated reprocessing instructions for 293 BF-XT160 bronchovideoscopes to comply with FDA 2015 guidance. Healthcare facilities should implement the new sterilization and disinfection procedures.
Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder Pills due to out-of-specification test results from identification testing. Ten bottles nationwide have been affected.
Johnson & Johnson Consumer is recalling Neutrogena Ultra Sheer body mist sunscreen in 5 oz and 8 oz aerosol cans nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.
Borinquen Cones of Puerto Rico is recalling Crunchy Cones Chocolate (12-count, 40oz boxes, Lot 24521) because the product label does not declare the presence of sulfites.
Washington Homeopathic Products is recalling ZTE-1035 Formula, an antimicrobial homeopathic combination product, due to out-of-specification test results for identification testing based on HPTLC analysis.
Washington Homeopathic Products is recalling Aconitum nap Fear 20% Alcohol homeopathic medicine (Lot #26198) distributed nationwide due to out-of-specification test results from HPTLC identification analysis.
Johnson & Johnson Consumer is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 100+ nationwide due to manufacturing deviations. Approximately 3.98 million cans are affected.
Washington Homeopathic Products, Inc. is recalling Z-1070 Formula Anxioheal, a 1000ml homeopathic remedy containing 20% alcohol, due to out-of-specification test results from HPTLC identification testing. The product was distributed nationwide.
Washington Homeopathic Products is recalling Occular Allergy Blend 87% Alcohol (Lot # 30148, 500 mL bottles) distributed nationwide due to out-of-specification test results in identification testing.