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.
Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles distributed nationwide.
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during stability testing. The affected lot was distributed nationwide.
Trimble is recalling 127 RTS873 robotic total stations because the green aiming laser output power may exceed its Class 2 laser safety classification. Units were produced between October 2023 and February 12, 2025 and distributed in the US, South Korea, and United Kingdom.
Belmont Instrument is recalling the Straight Inflow/Bifurcated Outflow Line Kit (Model 902-00038) due to potential cracks in the female connector on the Heat Exchanger set, which may cause fluid leaks during priming.
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.
Medline Industries is recalling Non Sterile I&D Kit procedure kits (Lot 23KDB283) because Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide, including the US, Panama, and Canada.
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Belmont Instrument LLC is recalling 158 Hyperthermia Pump Procedure Kits (Model 902-00045) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leakage during use.
Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for use.
Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.
USDA FSIS issued a public health alert for mixed potato chip products containing pork cracklings imported from Colombia, a country ineligible to export meat to the U.S.
Request Foods Incorporated is recalling Moroccan Style Lentil Soup due to potential contamination with wood fragments. The product was distributed in Illinois and Michigan.
Apipharma is voluntarily recalling Kapsin Ointment (Camphor 3.16% and Capsaicin 0.03%) distributed in Arizona due to Current Good Manufacturing Practice (CGMP) deviations.
Pacific Meridian Group, LLC is recalling Gold Garlic Powder Irradiated due to potential contamination with foreign objects (metal). The recalled product was distributed in CA, IL, and TX.
Pharmadel, LLC is recalling Urodel homeopathic chewable tablets for urinary tract infection symptom relief due to cGMP manufacturing deviations. The voluntary recall affects 10,752 bottles distributed in Delaware.
Zimmer, Inc. is recalling a ceramic hip prosthesis head because its labeling does not adequately describe compatibility with cobalt-chrome or stainless-steel femoral stems.
Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers running Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze unexpectedly during sample measurement, causing test results to be lost and delayed.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules nationwide due to elevated levels of a nitrosamine-related impurity that exceed the FDA's interim safety limit. The affected lots include bottles with expiration dates in April 2027.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer may lose connection to laboratory information systems, interrupting sample processing and delaying patient test results.
Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 bottles distributed in Delaware.
RemedyRepack Inc. is recalling Clindamycin HCl 300 mg Capsules due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 1,858 30-count blister cards distributed in Pennsylvania.
Pharmadel is recalling 6,048 bottles of Rapidol Arnica Tablets homeopathic medicine due to current good manufacturing practice (cGMP) deviations. The recall affects bottles with lot EAT-01, expiration date March 27, distributed in Delaware.
OurPharma LLC is recalling HYDROmorphone Hydrochloride 50 mg/50 mL cassettes nationwide because the assay results showed higher potency than specification.
Abbott Molecular is recalling the Alinity m System due to a design flaw that may allow liquid waste or system solutions to spill beyond the instrument footprint into the user's walking path.