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.
Ergoactives is recalling 278 HeaterBaum Foot & Ankle Heating Pads because they were marketed without a cleared 510(k).
Reliable Drug is recalling all T4-levothyroxine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all TRIE products because of a lack of processing controls. The recall covers lots compounded between March 24, 2015, and March 24, 2016.
Reliable Compounding Pharmacy is recalling all hydroxyzine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all T3 products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug is recalling all compounded estradiol products due to a lack of processing controls. The recall covers lots compounded between March 2015 and March 2016.
Reliable Drug is recalling compounded Malarone products due to a lack of processing controls. The recall covers all lots compounded between March 24, 2015, and March 24, 2016.
Hummingbird Med is recalling 62,400 Hummi Micro Draw Blood Transfer Devices distributed in California due to insertion difficulties.
Musculoskeletal Transplant Foundation is recalling 114 AFT Diverted Tubes because an unsealed Tyvek pouch could introduce contamination into the sterile field.
Reliable Drug is recalling all lidocaine, tetracaine, and benzocaine compounded products due to a lack of processing controls.
Reliable Drug is recalling all carbomer products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug is recalling all clobetasol products compounded between March 2015 and March 2016 due to a lack of processing controls.
Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05% sample packs due to failed content uniformity specifications.
Allergan is recalling Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications. The recall covers 17,802 units distributed nationwide and in Puerto Rico.
Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.
Reliable Drug is recalling all diethylstilbestrol products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all ketamine and amitriptyline products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug/Reliable Compounding Pharmacy is recalling all compounded prescription products due to a lack of processing controls. The recall covers lots compounded between March 2015 and March 2016 distributed in California, Hawaii, and New Mexico.
Reliable Drug is recalling all tetracaine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Drug is recalling all sulfapyridine products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Compounding Pharmacy is recalling all dyclonine products compounded between March 2015 and March 2016 due to a lack of processing controls.
ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.
Zarbee's Naturals is recalling specific lots of Baby Vitamin D liquid supplements because some units contain elevated aerobic plate counts and do not meet visual appearance standards.
Reliable Compounding Pharmacy is recalling all coal tar products compounded between March 2015 and March 2016 due to a lack of processing controls.
Reliable Rexall-A Compounding Pharmacy is recalling all fluocinonide products compounded between March 2015 and March 2016 due to a lack of processing controls.