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.
Borris Brothers voluntarily recalled Smoked Mahi Dip (8oz and 48oz) in Florida due to undeclared Yellow #5 food dye. Consumers sensitive to this color additive should not consume the product.
The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.
DAISO CALIFORNIA WAREHOUSE is recalling Ribbon raw thigh candy because fish is listed without identifying the species, creating uncertainty for consumers with fish allergies.
American Woodmark Corporation is recalling about 235,000 Continental Cabinets and Hampton Bay kitchen wall cabinets that can detach from walls, posing an impact hazard. The company will provide free repair kits with brackets and installation assistance.
World Market is recalling about 6,300 Gold Metal and Ribbed Glass Cocktail Shakers because the glass can crack and break during use, posing a laceration hazard. The firm has received three reports of cracking or breaking, including two incidents of lacerations that did not require medical attention.
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.
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.
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.
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.
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
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.
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).
PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.
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.
PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.
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.
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.
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.
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
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.
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.
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.
20-100 Delicious Seasoning LLC recalls Sofrito Marinating Sauce because the product was not stored refrigerated as required. Consumers should not consume the product.