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.
Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
Albertsons Companies LLC is recalling Signature Select Oat & Nuts Bread (20 oz) due to potential undeclared tree nut allergens from cross-contamination. Consumers with tree nut allergies should not consume affected products.
Signature Select Nuts & Grain Bread may contain undeclared tree nuts from potential cross contamination. The product is distributed in Western U.S. states and poses a risk to consumers with tree nut allergies.
Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.
Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
Novis PR, LLC is recalling PreProtein Liquid Predigested Protein dietary supplement because certain bottles are bloated. The recall affects approximately 4,106 units from lot 230118.
PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
Simply Good Foods is recalling Atkins Milk Chocolate Delight Protein Shakes nationwide due to post-processing contamination that may cause spoilage. Affected products have lot numbers SA2208P3F6 (exp. 07/27/23) or SA2210P3F6 (exp. 07/29/23).
ODL Inc. is recalling Severe Weather Doorglass Inserts sold at Home Depot and Lowe's because the adhesive bond can separate during hurricanes, creating a risk of injury and property damage from windborne debris.
Berkshire Innovations is recalling about 990 Sahara Folding Food Dehydrators because the heater fan can fail and cause the unit to overheat, posing a fire hazard. No injuries or property damage have been reported.
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.
Northwind Pharmaceuticals is recalling 99 bottles of Atorvastatin Calcium 10 mg tablets nationally due to manufacturing process deviations identified in March 2023.
Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.