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.
Pfizer is recalling 7,824 bottles of ethosuximide capsules because the expiration date on the label is incorrect.
EPI Health is recalling 1,626 bottles of Minolira extended-release tablets because they failed dissolution specifications. The recall is limited to EPI field representatives.
Randox Laboratories is recalling Randox Urinalysis Control Level 2 kits because the leukocyte range for the Siemens Multistix method was incorrect.
Pfizer is recalling 7,686 bottles of Zarontin (ethosuximide) capsules because the expiration date on the label is incorrect.
Philips Healthcare is recalling two DigitalDiagnost C50 stationary X-ray systems in Puerto Rico due to a missing label identified during recent evaluations.
CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.
Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.
Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to include specific information on tether removal during implant.
American Health Packaging is recalling Lamivudine Tablets due to an error in the package insert that incorrectly lists tablet description coding.
Medtronic is updating the Micra Pacemaker Instructions for Use and Implant Procedure Tip Card to clarify tether removal during implant.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.
Getinge is recalling 1,444 boxes of disposable CO2 absorbers because the expiration and manufacturing dates on the labels are reversed.
Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.
Aurobindo Pharma USA Inc. is recalling 2,352 bottles of 40 mg Simvastatin tablets because some bottles were labeled with the wrong lot number and expiration date.
Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.
Oculogica is recalling three EyeBOX Model OCL 02 units because the user manual is missing two precaution statements.
Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.
Cincinnati Sub-Zero is recalling 2,079 MICRO-TEMP LT heat therapy systems because updated warnings indicate that exceeding 40°C for extended periods may cause tissue damage.
Glenmark Pharmaceuticals is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate Cream due to complaints of a liquidy texture caused by temperature abuse.
Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.
Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.
Sage Products Inc is voluntarily recalling a lot of Independent Care System kits because the included Sodium Bicarbonate Mouthpaste tubes may be cosmetically damaged.
Sunshine Bottling Co. is recalling specific lots of Sunchy Malta beverage because the product did not meet taste specifications.