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.
Get Tested International AB is recalling 1557 units of its Vitamin D-Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 17 units of its DHEA Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 18 units of its Neurotransmitters Basic because the product was distributed without premarket approval or clearance.
CA Botana International is recalling 1,167 tubes of Doctor D. Schwab Mineral Sunscreen SPF 50 for CGMP deviations.
Philips is recalling 172 Azurion 7M20 systems with FlexArm because motorized longitudinal movement of the stand may be inconsistent and eventually become unavailable.
CA Botana International is recalling 555 tubes of Doctor D. Schwab Controlling Balm with Tea Tree Oil for CGMP deviations.
CA Botana International is recalling 2,090 tubes of Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 for CGMP deviations.
CA Botana International is recalling 874 tubes of Sea Enzyme Ultra Umbrella Sunscreen SPF 30 for CGMP deviations.
Foundation Medicine is recalling 59 FoundationOne CDx reports that were sent to customers without the companion diagnostic Claims Page.
CA Botana International is recalling 4,890 bottles of Dr. Bump Natural Pain Relief Gel with Menthol 5% for CGMP deviations.
Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.
CA Botana International is recalling 1,617 tubes of Gabriel Mineral Sunscreen SPF 50 for CGMP deviations.
Cepheid is recalling 9,880 Xpert MTB/RIF cartridges from one lot because product testing did not meet expected stability criteria.
Alcon Research is recalling 28,323 Constellation UltraVit 10K and HyperVit 20K vitrectomy probe packs; the enforcement record does not state a reason.
CA Botana International is recalling 3,295 bottles of Elixir by Coco March Mineral Sunscreen SPF 50 for CGMP deviations.
Remel is recalling cation-adjusted Mueller Hinton broth and Brucella broth because the products may contain contamination, which may result in a darker or brown media color.
CA Botana International is recalling 4,890 bottles of CLEARSTEM You Are Sunshine SPF 50 for CGMP deviations.
CA Botana International is recalling 1,401 tubes of Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50 for CGMP deviations.
CA Botana International is recalling 810 tubes of Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica for CGMP deviations.
CA Botana International is recalling 805 tubes of Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 for CGMP deviations.
CA Botana International is recalling Elixir by Coco March Tinted Mineral Sunscreen SPF 50 for CGMP deviations.
CA Botana International is recalling 470 tubes of Doctor D. Schwab Controlling Cream with Benzoyl Peroxide 2.7% for CGMP deviations.
Foundation Medicine is recalling 18 FoundationOne Liquid CDx reports that were sent to customers without the companion diagnostic Claims Page.
CA Botana International is recalling 1,492 tubes of Karina Daily Moisturizer SPF 25 for CGMP deviations.
Imprimis NJOF is recalling 67,091 bottles of compounded Klarity-C Drops (Cyclosporine) 0.1% preservative-free ophthalmic emulsion as a subpotent drug.