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.
Advanced Accelerator Applications recalls approximately 14,089 NETSPOT kits distributed nationwide due to subpotency detected during stability studies. The affected lots contain insufficient active ingredient concentration.
Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.
SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.
Sun Pharmaceutical recalls CEQUA cyclosporine ophthalmic solution nationwide due to low assay results and particulate matter found in specific lots.
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.
Ritedose is recalling 3,795 prefilled syringes of sodium chloride injection nationwide. The barcodes incorrectly identify the product as rocuronium bromide, creating a medication identification risk in healthcare settings.
Stokke is recalling white Clikk high chairs because the plastic seat can break, creating a fall and injury hazard to children. The company has received six reports of seat breakage, including two reports of minor bruises.
Ansell is recalling Gammex Non-Latex PI Green surgical gloves (size 7 1/2) because the product was not submitted for required FDA inspection at the border. Distribution included Arizona, California, Nevada, Texas, Utah, and Washington.
Microbiologics Inc recalls the Pneumonia (33 Targets) Control Panel due to a shelf-life discrepancy. The product's shelf-life was determined to be 6 months instead of the labeled 18 months.
Dr. Reddy's Laboratories is recalling 28,068 bottles of Atorvastatin Calcium 80 mg tablets nationwide due to failed impurity and degradation specifications. No illnesses or injuries have been reported.
Elmer Candy Corp is recalling Elmer's Pecan Egg candies due to pecan tree bark in the product. The recall affects 370,464 units from lot 2930 distributed in eight states.
Taro Pharmaceuticals recalls Clotrimazole and Betamethasone Dipropionate cream after a stability sample failed potency testing. The recall affects 768 tubes distributed to a retailer in New York, expiring June 2023. No illnesses have been reported.
Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
Baxter Healthcare is recalling 498 units of MiniCap Extended Life PD Transfer Sets because they were distributed without FDA regulatory clearance. Affected units were distributed in 16 U.S. states.
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
Dr. Reddy's Laboratories is recalling 7,703 bottles of Lansoprazole Delayed-Release Capsules (30 mg, 90-count) nationwide due to failed dissolution specifications found during long-term stability testing.
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.
Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5% (150 mL) nationwide due to defective containers that may leak. Consumers who have purchased this product should stop use and contact their pharmacy or physician.
Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.
Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.