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.
Certain 2022 Heartland Sundance travel trailers have incorrect tire information on their Federal and Certification labels. This could lead to incorrect tire replacement and potentially affect towing safety.
Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.
Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.
Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.
About 77,900 Harbor Breeze Belleisle Bay and Honeywell Rio ceiling fans are recalled because the blades can detach during use and strike consumers or cause property damage.
Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.
Gerber is recalling Macaroni and Cheese with peas and carrots due to beetles found in the pea ingredient in the side compartment. The affected product has a best-by date of 04 Oct 2022.
Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.
Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg tablets nationwide due to a product mix-up. The recall affects 9,744 bottles and was voluntarily initiated by the manufacturer.
Puratos Corporation is recalling approximately 119,900 lbs of TK019 2017 Choc Cup Powder Blend due to potential metal contamination. Affected batch numbers are 0010636571 and 0010636577.
Puratos Corporation is recalling TK006 Van Krimpet Powder Blend (50 lb bags, item number 4107780) because the product may contain foreign metal material. The affected batches are 0010636568 and 1110644921.
NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.
Puratos Corporation is recalling Teg Moist'r Yellow Layer Cake Mix (50# bag, Batch Number 10737143) due to potential metal contamination. The product was distributed to customers across 12 U.S. states and 2 foreign countries.
Puratos Corporation is recalling Easy Satin Supreme Creme Cake Bag 50# due to potential metal contamination. The affected product was distributed to bakery and food manufacturers in twelve U.S. states and two Caribbean countries.
Puratos Corporation is recalling Teg Creme Cake Bags (50 lb) because they may contain foreign metal material. The affected product was distributed to customers in multiple U.S. states and internationally.
DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.
Flowers Foods is recalling Tastykake Chocolate Creme Filled Cupcakes due to the potential presence of small metal fragments in an ingredient. The affected product has an "Enjoy By" date of December 14 or December 18.
Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.