Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
GlaxoSmithKline is recalling TUMS Ultra Assorted Berries 1000mg chewable tablets because they may contain foreign TUMS 750mg tablets.
Actavis Inc is recalling 15,132 bottles of BuPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because dissolution test results exceeded approved limits.
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.
Novartis Consumer Health is recalling No Doz Max Strength caplets because the pouches may not be fully sealed.
Hospira Inc. is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Cordis Corporation is recalling 33,000 units of the OPTEASE Retrieval IVC Filter to provide additional labeling that minimizes the likelihood of implanting the filter backwards.
Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient Avobenzone may be subpotent, reducing sunscreen effectiveness.
Watson Laboratories is recalling two lots of Oxycodone and Acetaminophen Capsules because the oxycodone content was found to be below specification at expiry.
National Biological Corp is recalling Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-083 device.
Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.
National Biological Corp is recalling six Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-080 device.
Pharmalucence, Inc. is recalling Technetium Tc 99m Sestamibi Injection kits due to the presence of particulate matter found in retained samples.
Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because of orange to brown discoloration found on the inner foil seal.
Technidata is recalling TDHistology/Cytology software because unsupported symbols in Microsoft Word reports may cause errors during electronic transmission of results.
Boston Scientific is recalling 35 units of Alair Bronchial Thermoplasty Catheters because the expiration date on the inner tray is incorrect.
Bayer HealthCare Pharmaceuticals Inc. is recalling 194.62 kg of Medroxyprogesterone acetate API because it failed stability specifications for particle size.
Teva Pharmaceuticals is recalling Junel oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.
Boston Scientific is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator because they were labeled with an incorrect expiration date.
West-ward Pharmaceutical Corp. is recalling specific lots of Nicardipine Hydrochloride Injection because they failed impurity specifications for a degradation product.
Teva Pharmaceuticals is recalling Lessina oral contraceptives because an impurity was detected during testing. The FDA classifies this as a Class III recall.
Teva Pharmaceuticals is recalling specific lots of Jolessa birth control tablets because an impurity was detected during testing.
Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.
Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.
Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.
Becton Dickinson is recalling 71 BD MAX instruments because the installed electrical power module does not meet industry standards as labeled.