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.
Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel nationwide due to deviations from proper manufacturing practices.
Linus Bike is recalling about 430 electric bicycles (Cesta 500 and Ero 500 models) because the front fork can crack, posing a crash hazard. No injuries have been reported.
An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.
Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.
WeeSprout baby sleep sacks are being recalled because the zipper can detach, posing a choking hazard to infants. The company has received 17 reports of zipper detachment but no injuries have been reported.
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
Frenda Corporation voluntarily recalled 44,140 bottles of Easy Clean 75% Ethyl Alcohol sold in Puerto Rico due to manufacturing practice deviations.
DISCOVERY PHARMA LLC voluntarily recalled 21,892 tubes of Conzerol zero molluscum contagiosum topical cream distributed in California, Florida, and Washington due to current good manufacturing practice deviations.
Professional Complementary Health Formulas, LLC recalls Vitamin B Complex dietary supplement (lot 1092715) due to undeclared niacin affecting 299 bottles distributed nationwide.
Global Care 70% Alcohol Ethyl Rubbing Alcohol, distributed in Puerto Rico, has been voluntarily recalled by Frenda Corporation due to manufacturing compliance deviations. The recall affects 12,130 bottles in multiple package sizes.
Frenda Corporation is voluntarily recalling Easy Clean Isopropyl Alcohol 99%, 1-gallon bottles (164 units) due to current Good Manufacturing Practice deviations. The product was distributed in Puerto Rico, lot C030121.
Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution due to manufacturing practice deviations. The recall affects 144 bottles distributed in Puerto Rico.
Niagara Bottling is recalling Limited Edition Winter Mint Chocolate Premier Protein Shakes distributed in CA, GA, and OH because they did not undergo proper processing and may be spoiled.
The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.
Frenda Corporation recalls Easy Clean Alcohol Surface Disinfectant Cleaner due to cGMP deviations. The recall affects 8,475 bottles distributed in Puerto Rico.
FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.
Frenda Corporation is recalling Easy Clean 70% Isopropyl Alcohol due to manufacturing practice deviations. The recall affects 65,376 bottles distributed in Puerto Rico.
Professional Complementary Health Formulas is recalling Inositol dietary supplement (Lot 1032526, UPC 4065111562) distributed in NY, OR, PA, UT, WI, and WY due to undeclared niacin. Consumers should stop using the product.
Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.
Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
Nephron Sc Inc recalls approximately 925,920 vials of S2 Racepinephrine Inhalation Solution due to short fill. Affected lots may contain less medication than labeled.
OurPharma LLC is recalling 768 cassettes of FentaNYL Citrate injection solution due to underfilled units. The affected product was distributed in Illinois and Missouri.