Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

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.

901–925 of 2741

LowFDA (Drugs)·D-0249-2019·2018-10-24
Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling Temozolomide capsules because stability testing revealed out-of-specification dissolution results.
Product
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0025-2019·2018-10-24
Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors
Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.
Product
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0070-2019·2018-10-24
Cicatricure Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0016-2019·2018-10-17
Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling
Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.
Product
ALTAVERA — ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0081-2019·2018-10-17
BD FocalPoint Slide Profiler Recalled for Temperature Limit Labeling Error
Becton Dickinson is recalling BD FocalPoint Slide Profiler and GS Review Station units because they may not function below 15°C. The agency states this issue has no potential to cause harm.
Product
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence…
Category
Medical Device
Distribution
Distributed nationwide
LowNHTSA·18V711000·2018-10-11
Toyota Recalls 2018-2019 Tundra for Incorrect Load Capacity Label
Toyota is recalling 2018-2019 Tundra vehicles because the load carrying capacity label incorrectly overstates weight by 10 pounds, failing federal safety standards.
Product
TOYOTA — TOYOTA TUNDRA
Category
Vehicle
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0017-2019·2018-10-10
Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits
Otsuka is recalling 17,325 treatNOW Abilify physician sample kits due to labeling errors, including misspelled product names and missing storage instructions.
Product
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement.…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0074-2019·2018-10-10
Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error
Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0075-2019·2018-10-10
Smiths Medical Portex Nasal Oxygen Cannula Recalled for Labeling Error
Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.
Product
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0018-2019·2018-10-10
Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits
Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.
Product
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0062-2019·2018-10-10
Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.
Product
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0072-2019·2018-10-10
Smiths Medical Nasal Cannula Recalled for Incorrect Labeling
Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0073-2019·2018-10-10
Smiths Medical Portex Nasal Cannula Recalled for Labeling Error
Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0071-2019·2018-10-10
Smiths Medical Nasal Cannula Recalled for Transposed Date Labels
Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.
Product
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0104-2019·2018-10-03
Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
Dr. Reddy's Laboratories is recalling 10,530 vials of Zoledronic Acid Injection because of out-of-specification unknown impurities.
Product
ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0103-2019·2018-10-03
Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities
Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection vials because they failed impurity specifications with out-of-specification unknown impurities.
Product
ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-3253-2018·2018-10-03
Medtronic Diagnostic Catheter Recalled for Incorrect French Size Labeling
Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.
Product
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Category
Medical Device
Distribution
7 states
LowFDA (Food)·F-1988-2018·2018-10-03
Caffeine-Free Barq's Root Beer Recalled for Mislabeling
Swire Coca Cola USA is recalling Caffeine-Free Barq's Root Beer 12 Packs due to mislabeling. The recall covers 2,945 cases distributed nationwide.
Product
Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3252-2018·2018-10-03
Biomet Sports Medicine Drill Bit Recalled for Incorrect Expiration Date Labeling
Zimmer Biomet is recalling 217 units of Biomet Sports Medicine Juggerknot Long Flex Drill Bits because the expiration date is incorrectly listed on the label.
Product
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-3184-2018·2018-09-26
Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.
Product
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-1970-2018·2018-09-26
Stewart's Ice Cream Recalled for Incorrect Lid Packaging
Stewart's Shops Corp. is recalling 5,455 pints of Caramel Cone Crunch ice cream because some containers were packaged with the wrong lid.
Product
Stewart's Ice Cream Caramel Cone Crunch Carton, 1 pint, keep frozen, UPC: 082086444718
Category
Food
Distribution
2 states
LowFDA (Drugs)·D-1214-2018·2018-09-26
Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity
Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because testing found an impurity exceeding safety limits.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3193-2018·2018-09-26
Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.
Product
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3196-2018·2018-09-26
Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits
Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.
Product
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1212-2018·2018-09-26
InvaGen Recalls Bupropion Hydrochloride Tablets Due to Impurity Levels
InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride ER tablets because older batches failed impurity specifications.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide