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.
Cesarina Bakery is recalling Flora Raspberry Sandwich Pastries because they contain undeclared milk, which poses a risk to consumers with milk allergies. The recall affects 1,028 cases distributed domestically.
Medline Industries is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls due to improper storage conditions. The product was shipped at room temperature instead of the required refrigerated environment.
Black Rifle Coffee Company is recalling Black Rifle Coffee Mac V Whole Bean Coffee 12oz bags due to the possible presence of plastic within the final product packaging. The affected product was distributed in Tennessee.
Coca Cola Consolidated LLC is recalling Sprite 12 oz. aluminum cans distributed to Arkansas, Mississippi, and Tennessee due to potential foreign matter in containers.
San Mar Manufacturing Corporation is recalling Hacienda Las Glorias Premium Bebida de Parcha (Passion Fruit Drink) 16 oz. bottles due to undeclared Yellow #5 dye. The product was distributed domestically only.
Scott Fetzer Consumer Brands is recalling about 43,200 American Angler Electric Fillet Knives because the trigger mechanism can become stuck in the "on" position, posing a laceration hazard to users.
Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.
Cesarina Bakery, Inc. is recalling Flora Pastries Butter Cookies because they contain undeclared milk, which poses a hazard to consumers with milk allergies. The recall affects 37 cases distributed domestically.
Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.
Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.
Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg due to superpotency. The affected batch (BZ74G001, expiring 12/2021) contains approximately 27,312 bottles distributed nationwide.
Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.
Kraft Heinz Foods Company is recalling Kool-Aid cherry drink mix powder in multiple sizes due to potential glass and metal contamination. The recall affects 289,221 cases distributed nationwide and internationally.
TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, nationwide due to a superpotent (higher-than-intended active ingredient) formulation. The voluntary recall affects three specific lots.
Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.
Kraft Heinz Foods Company is recalling Tang orange drink mix powder in three sizes due to potential contamination with glass and metal particles. The affected product was distributed nationwide and internationally.
Mother's Milk Bank of North Texas is recalling 54 bottles of pasteurized donor human milk (100 mL each, batch 025958-1) distributed in Texas because a foreign object was found in a bottle.
Kraft Heinz Foods Company is recalling Kool-Aid strawberry drink mix powder (19 oz.) due to potential glass and metal contamination. The recall affects approximately 289,221 cases distributed nationally and internationally.
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.
Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.
CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.
Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.
Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.
Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.