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.
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Microbiologics Inc is recalling KWIK-STIK 2 Pack Trichosporon dermatis cultures because they may contain Candida utilis instead of the labeled organism.
Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Herbal Doctor Remedies is recalling Age Back 500 mg capsules because they are misbranded as unapproved new drugs.
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Herbal Doctor Remedies is recalling Reman-AP 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.
Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to a potentially insufficient cleaning process or inadequate process monitoring.
Herbal Doctor Remedies is recalling Herpes Soap because the product is misbranded as an unapproved new drug. The soap was sold online in the US and internationally.
Herbal Doctor Remedies is recalling Reman-8 capsules because the products are misbranded as unapproved new drugs.
Herbal Doctor Remedies is recalling Acne Cystic 500 mg capsules because they are misbranded as unapproved new drugs.
Herbal Doctor Remedies is recalling Dermatoxin 500mg capsules because they are misbranded as unapproved new drugs.
Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.
Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.
Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Herbal Doctor Remedies is recalling Detoxin Ex capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.
Herbal Doctor Remedies is recalling Pain Away 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.
Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug.
Herbal Doctor Remedies is recalling Stomach Cleanser capsules because the products were found to be misbranded as unapproved new drugs.
Herbal Doctor Remedies is recalling Herpes V Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.
Herbal Doctor Remedies is recalling Skin Lift Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.
Herbal Doctor Remedies is recalling Sperm Booster because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.
Herbal Doctor Remedies is recalling Detoxin-S 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.
Herbal Doctor Remedies is recalling Pain Stopper 500mg capsules because they are misbranded as unapproved new drugs.