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.
Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.
Family Dollar is recalling about 800 beach lounge chairs that can collapse unexpectedly, risking finger entrapment in metal folding joints. The loungers were sold nationwide from January 2019 through September 2021.
Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.
Aroma Meats LLC is recalling Curry Leaf Hot Pickle packaged in white plastic pouches (500 grams) distributed in Oregon because the product was from an unapproved source.
RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.
Torrent Pharma Inc. is recalling Carbamazepine 200 mg tablets nationwide because they failed to meet dissolution specifications, which means the tablets may not release the medication properly in the body.
The Natural Dentist Healthy Balance Peppermint Sage mouthwash (16.9 FL OZ, Lot 2091A) has been recalled due to a back label mix-up. The label incorrectly identifies the active ingredient as Menthol with the wrong UPC code instead of the correct Peppermint Oil and Sage Oil.
Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL distributed nationwide due to missing label.
Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.
Gentherm Medical is recalling 484 Electri-Cool II cold therapy units (Model 767) distributed worldwide to provide updated labeling with revised operating instructions for Cold Therapy pads.
Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.
Textron Specialized Vehicles is recalling about 280 E-Z-GO Freedom RXV personal transportation vehicles with rear-facing seats because the rear seat structure can fail and tilt unexpectedly, creating a fall and injury hazard. Consumers should stop using the rear-facing seat and contact Textron for a free repair.
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.
Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.
Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.
Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels detected during stability testing.
Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.
Amazon Basic+Care Allergy Fexofenadine Hydrochloride Tablets (60 mg, 100-count) are being recalled because impurity levels exceeded acceptable limits during stability testing. The recall affects 38,352 bottles distributed nationwide.
Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.
Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.
Keurig Dr Pepper is recalling Diet Snapple Peach Tea 16 oz bottles with expiration date February 5, 2022, because some units labeled as diet and zero sugar may contain sugar due to a production error.
Prepared Meals Co is recalling Happi Foodi Roasted Russets and Asparagus frozen bowls (10 oz) due to the presence of visible mold detected in the product.
Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications during stability testing.