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.
The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.
Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.
PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.
IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.
Zimmer, Inc. is recalling the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Lot 66232947) after a complaint reported a posterior augment found inside the distal augment package.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
El David Gelee Bonbons with fruits (400g boxes) are recalled due to undeclared FD&C Yellow 5 and FD&C Red 40 color additives. Consumers who have purchased this product should not consume it.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.
Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.
Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.
Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.
Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.
Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.
Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.
Jayco is recalling 2024 Alante and Entegra Vision recreational vehicles because the occupant and cargo capacity labels may list incorrect weights, potentially leading to vehicle overloading.
Cura Hongos Crema Antifungica, clotrimazole 1%, in 2 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 84 tubes affected.
Med Pride Hydrocortisone Cream 1%, 16 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,738 tubes are affected.
Medline C-section kits, packs and recovery kits are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.