Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

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.

20551–20575 of 21633

ModerateFDA (Drugs)·D-306-2013·2013-05-08
Donnatal Extentabs Recalled for Incorrect Expiration Date Labeling
West-ward Pharmaceutical is recalling 1,258 bottles of Donnatal Extentabs because the bottles are labeled with an expiration date of April 2015 instead of the correct April 2013.
Product
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1187-2013·2013-05-08
Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect
Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.
Product
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1180-2013·2013-05-08
Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators
Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1355-2013·2013-05-08
Vanilla Eskimo Dessert Bar Recalled for Undeclared Food Dye
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz Vanilla Eskimo Dessert Bars because the product contains undeclared FD&C Yellow #6.
Product
Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-304-2013·2013-05-08
Warner Chilcott Recalls Jevantique Tablets Due to Chemical Contamination
Warner Chilcott is recalling Jevantique tablets because 2-phenylphenol was found in the product. The contamination resulted from migration from the cardboard cartons used for packaging.
Product
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0999-2013·2013-05-08
Trophy CareStream Dental CS 2100 X-ray System Recalled for Defective Connector
Trophy Sas is recalling CareStream Dental CS 2100 X-ray systems due to a bent connector causing poor contact in the high-tension transformer power pin.
Product
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1080-2013·2013-05-01
Stellate Systems Recalls Harmonie Software Due to FDA Clearance Issues
Stellate Systems is recalling Harmonie software versions 5.1 to 6.2e because the product's labeling indications have not been cleared by the FDA for sale in the USA.
Product
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1163-2013·2013-05-01
Varian RPM Respiratory Gating System Recall for Waveform Anomaly
Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.
Product
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-298-2013·2013-05-01
Qualitest Recalls Glimepiride Tablets Due to Oversized Tablet Finding
Qualitest Pharmaceuticals is recalling 10,373 bottles of Glimepiride 2 mg tablets because one oversized tablet was found in a sealed bottle at the retail level.
Product
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-299-2013·2013-05-01
Pentrexcilina Tablets Recalled for Misleading Labeling Confusion
OPMX, LLC is recalling Pentrexcilina tablets because the labels are misleading and may be confused with a prescription antibiotic.
Product
Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1173-2013·2013-05-01
DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state they retain 100% strength at six weeks, when they actually retain approximately 80%.
Product
ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-300-2013·2013-05-01
Pentrexcilina Liquid Recalled for Misleading Labeling Confusion with Prescription Antibiotic
OPMX, LLC is recalling Pentrexcilina Jarabe NF liquid because its label may be confused with Pentrexyl, a prescription antibiotic.
Product
Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1346-2013·2013-05-01
Jasmine Garlic Crackers Recalled for Undeclared Food Dyes
Wira Corp. is recalling Jasmine Garlic Flavored Crackers due to undeclared and unapproved food color ingredients.
Product
Jasmine Brand Garlic Flavored Crackers (Krupuk Bawang), 40x250gr.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1344-2013·2013-05-01
Ozone Confectioners Recalls Non-Pareil Seeds Due to Undeclared Dyes
Ozone Confection & Bakers Supply Co. is recalling 481 units of Non-Pareil Seeds because they contain undeclared FD&C colors.
Product
Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-1178-2013·2013-05-01
Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision
Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.
Product
The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1343-2013·2013-05-01
Ozone Confectioners Recalls Non-Pareil Seeds Due to Undeclared Dyes
Ozone Confection & Bakers Supply Co. is recalling 481 boxes of Non-Pareil Seeds because they contain undeclared FD&C colors.
Product
Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Category
Food
Distribution
5 states
ModerateFDA (Food)·F-1345-2013·2013-05-01
Ozone Confectioners Recalls Easter Mix Non-Pareil Seeds for Undeclared Dyes
Ozone Confection & Bakers Supply Co. is recalling 481 units of Easter Mix Non-Pareil Seeds because they contain undeclared FD&C colors.
Product
Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-1174-2013·2013-05-01
DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
Product
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1158-2013·2013-05-01
Teleflex Medical Recalls Belly Bag Urine Collection Bags Due to Packaging Concerns
Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.
Product
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-297-2013·2013-05-01
Hospira Recalls Propofol Injectable Vials Due to Particulate Matter
Hospira Inc. is recalling 245,250 vials of Propofol Injectable Emulsion because a single visible particulate was found during a retain sample inspection.
Product
PROPOFOL — PROPOFOL (PROPOFOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1172-2013·2013-05-01
DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Labeling
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state that 100% suture strength remains at six weeks.
Product
ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1351-2013·2013-05-01
Royal Foods Recalls Pantai Thai Tea Due to Insanitary Conditions
Royal Foods, Inc. is recalling Pantai Thai Tea because a state audit found insanitary conditions, including a leaking roof and rodent activity, at the facility.
Product
Pantai Thai Tea The tea is packaged in a foil laminated pouch Product of Thailand
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1175-2013·2013-05-01
DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
Product
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1176-2013·2013-05-01
DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
Product
ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1108-2013·2013-04-24
Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.
Product
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Category
Medical Device
Distribution
Distributed nationwide