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.
The Procter & Gamble Company is recalling Align Digestive De-Stress Capsules due to failure to meet microbiological specifications. Approximately 23,928 cartons were intended for destruction but were redirected for online sale instead.
ROi CPS LLC is recalling 290 convenience kits containing IV Start Kits due to potential inadequacy in the validation of test methods used during manufacturing. Distribution was in Missouri.
Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.
Olympia Compounding Pharmacy recalled 1,276 vials of Ultratest testosterone injection nationwide. Prior to October 2021, the manufacturer failed to properly investigate environmental and personnel monitoring deviations per FDA manufacturing standards.
ROi CPS LLC recalled 950 IV Start Kit convenience kits due to potential inadequacy in manufacturing test method validation. No injuries reported.
Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.
American Health Packaging is recalling Cyanocobalamin Injection because the product contains insufficient active ingredient and is out of specification for assay. The recalled lots (CCC210008, CCC210009) were distributed in Alabama.
Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated prior to October 2021.
Glenmark Pharmaceuticals is voluntarily recalling 11,136 bottles of Zonisamide Capsules due to manufacturing quality control deviations. No illnesses have been reported.
Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL due to failure to properly investigate manufacturing process monitoring deviations that occurred before October 2021. The recall affects 7,161 vials distributed nationwide.
Glenmark Pharmaceuticals is recalling Zonisamide Capsules (100 mg) due to current good manufacturing practice (cGMP) deviations. Two lots were distributed nationwide.
Olympia Compounding Pharmacy is recalling 460 vials of Alprostadil 80 mcg/mL due to manufacturing quality control deviations related to improper investigation of environmental and personnel monitoring excursions prior to October 2021.
Amazon is recalling about 22,400 AmazonBasics School Classroom Stack Chairs because the frame welds can fail, creating a fall hazard. No injuries have been reported.
Polaris is recalling approximately 1,160 Model Year 2022 RZR Pro R 4 Premium and Ultimate recreational off-road vehicles due to a fire hazard from an incorrectly routed battery cable that can contact the prop shaft.
Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.
Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.
Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.
Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.
artnaturals Scent-Free Hand Sanitizer is recalled due to manufacturing process deviations. Approximately 570,268 bottles distributed nationwide are affected.
Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.
DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.
Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution because the manufacturing firm discontinued its stability study program, a CGMP violation. All products within their expiration dates are affected.
Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.
Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.
DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.