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.

1226–1250 of 2741

LowFDA (Drugs)·D-1039-2017·2017-08-09
Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.
Product
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Category
Drug
Distribution
Distributed nationwide
LowUSDA FSIS·090-2017·2017-08-09
Corn Maiden Foods Recalls Ready-to-Eat Beef Pies Due to Misbranding
Corn Maiden Foods is recalling ready-to-eat beef pies because they contain undeclared monosodium glutamate (MSG). No adverse reactions have been reported.
Product
Corn Maiden Foods, Inc. — Corn Maiden Foods, Inc. Recalls Ready-to-Eat Beef Products Due To Misbranding
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-2759-2017·2017-08-02
Smiths Medical CADD IV Administration Set Recalled for Missing Expiration Date
Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.
Product
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2756-2017·2017-08-02
PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers did not match the devices inside.
Product
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
Category
Medical Device
Distribution
1 state
LowUSDA FSIS·086-2017·2017-08-01
JBS USA Recalls Ground Beef Due to Styrofoam Contamination
JBS USA is recalling approximately 4,922 pounds of ground chuck beef produced on July 15, 2017, due to possible contamination with shredded Styrofoam packaging.
Product
JBS Prepared Foods-Tupelo Facility — JBS USA Inc. Recalls Beef Products Due To Possible Foreign Matter Contamination
Category
Food
Distribution
1 state
LowFDA (Drugs)·D-0980-2017·2017-07-26
Hospira Recalls Argatroban Injection Due to Impurity Specification Failure
Hospira is recalling 701 vials of Argatroban Injection because a denitroquinoline-related impurity exceeded specifications during testing.
Product
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0981-2017·2017-07-26
Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures
Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.
Product
Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0983-2017·2017-07-26
Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities
Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity specifications.
Product
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0998-2017·2017-07-26
Obagi-C Rx Night Cream Recalled for Missing Safety Information
Valeant Pharmaceuticals is recalling 844 bottles of Obagi-C Rx System C-Therapy Night Cream because the bottles are missing the product insert and outer carton containing safety instructions.
Product
Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0982-2017·2017-07-26
Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications
Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.
Product
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-2538-2017·2017-07-19
AB Hanson and Mohring Recalls Saltwell Sea Salt Bags Due to Foreign Material
AB Hanson and Mohring is recalling 14,238 bags of Saltwell sea salt products because they may contain pieces of foreign material.
Product
Salinity sea salt Saltwell, Saltwell 57 and Saltwell for Organic Use 50 lb. bags
Category
Food
Distribution
3 states
LowFDA (Drugs)·D-0974-2017·2017-07-19
Lupin Recalls Paroxetine Extended-Release Tablets Due to Dissolution Failure
Lupin Pharmaceuticals is recalling Paroxetine Extended-Release Tablets because they failed dissolution testing during stability studies.
Product
PAROXETINE — PAROXETINE (PAROXETINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2725-2017·2017-07-19
AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects
AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.
Product
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
Category
Medical Device
Distribution
Distributed nationwide
LowNHTSA·17V445000·2017-07-14
Forest River Recalls 2017 Rockwood Travel Trailers for VIN Label Error
Forest River is recalling 2017 Rockwood travel trailers because an incorrect check digit on the VIN label may hinder vehicle registration and safety recall tracking.
Product
FOREST RIVER — FOREST RIVER ROCKWOOD
Category
Vehicle
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0934-2017·2017-07-12
PharMEDium Recalls Ropivacaine HCl Injection Due to Labeling Errors
PharMEDium Services, LLC is recalling 21 pumps of Ropivacaine HCl 0.2% injection due to incorrect or missing lot and expiration dates.
Product
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0935-2017·2017-07-12
PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling two Bupivacaine HCl ON-Q pumps due to incorrect or missing lot and expiration date labeling.
Product
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2659-2017·2017-07-12
Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-Packaging
Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
Product
3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0932-2017·2017-07-12
PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors
PharMEDium Services is recalling 147 Ropivacaine HCl IV pumps nationwide because of incorrect or missing lot and expiration dates.
Product
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0930-2017·2017-07-12
PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling 79 Ropivacaine HCl IV pumps because of incorrect or missing lot and expiration dates.
Product
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0936-2017·2017-07-12
PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling
PharMEDium Services is recalling seven Bupivacaine HCl ON-Q pumps because of incorrect or missing lot and expiration dates.
Product
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0931-2017·2017-07-12
PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors
PharMEDium Services is recalling 22 Ropivacaine HCl pumps nationwide because of incorrect or missing lot and expiration dates.
Product
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0933-2017·2017-07-12
PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Lot and Expiration Dates
PharMEDium Services, LLC is recalling 10 Ropivacaine HCl 0.2% ON-Q pumps nationwide due to incorrect or missing lot and expiration dates.
Product
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2623-2017·2017-07-05
CryoLife BioGlue Surgical Adhesive Recalled for Incorrect Lot Labeling
CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.
Product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2627-2017·2017-07-05
Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date
Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.
Product
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B)…
Category
Medical Device
Distribution
4 states
LowFDA (Drugs)·D-0926-2017·2017-07-05
Gaviscon Chewable Tablets Recalled for High Magnesium Levels
Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.
Product
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Category
Drug
Distribution
Distributed nationwide