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.

1851–1875 of 2741

LowFDA (Drugs)·D-0021-2016·2015-10-21
Ohm Laboratories Recalls Loratadine Tablets Due to Assay Failure
Ohm Laboratories is recalling specific batches of loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0038-2016·2015-10-21
Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues
Ohm Laboratories is recalling Wal-itin Loratadine Orally Disintegrating Tablets because they failed potency testing. The FDA classified this as a Class III recall.
Product
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0034-2016·2015-10-21
Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay
Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0004-2016·2015-10-14
Blue Plate Light Mayonnaise Recalled for Incorrect Labeling
Reily Foods Co. is recalling one lot of Blue Plate Light Mayonnaise because the packaging displays the ingredient and nutrition information for regular Blue Plate Mayonnaise.
Product
Blue Plate(R) LIGHT MAYONNAISE, 18 Fl OZ (1 PT 2 OZ) 532, mL. UPC 47900-50638
Category
Food
Distribution
12 states
LowFDA (Food)·F-3264-2015·2015-10-07
Dixie Crystals Sugar Recalled for Foreign Matter Detection
Savannah-Imperial LP is recalling specific lots of Dixie Crystals sugar due to the detection of blue fiber in the product.
Product
Dixie Crystals, Sugar EFG, Net Weight 50 lbs and 2000 lbs., Imperial Sugar Company, Savannah, GA.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3259-2015·2015-10-07
Imperial Sugar Recalls Granulated Sugar Due to Foreign Matter
Savannah-Imperial LP is recalling 50-pound bags of Imperial Sugar granulated sugar because blue fiber was detected in the product.
Product
Imperial Sugar, Pure Granulated Sugar, Net wt. 50 lbs (22.6 kg), Distributed by Imperial-Savannah LP, Sugar Land, Texas 77478.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3261-2015·2015-10-07
Monarch Granulated Sugar Recalled for Foreign Matter Detection
Savannah-Imperial LP is recalling Monarch Granulated Sugar due to the detection of blue fiber in the product.
Product
Monarch, Granulated Sugar, Net Wt. 25 lbs and 50 lbs (22.88 kg), Distributed by US Foods, Inc., Rosemont, IL.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3260-2015·2015-10-07
West Creek Granulated Sugar Recalled for Foreign Matter
Savannah-Imperial LP is recalling West Creek Extra Fine Granulated Sugar because blue fiber was detected in the product.
Product
West Creek, Extra Fine Granulated Sugar, Net Wt. 25 lbs (11.3 kg), Distributed by Performance Food Group, Richmond, VA 23238.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3265-2015·2015-10-07
Imperial Sugar Recalls 2000 lb Bags Due to Foreign Matter
Savannah-Imperial LP is recalling 2000 lb bags of Imperial GMI Non GMO Linerless Sugar EFG because blue fiber was detected in the product.
Product
Imperial GMI, Non GMO Linerless Sugar EFG, Net Weight 2000 lbs., Imperial Sugar Company, Savannah, GA.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3262-2015·2015-10-07
Savannah-Imperial Recalls Clear Value Sugar Due to Foreign Matter
Savannah-Imperial LP is recalling Clear Value Sugar because blue fiber was detected in the product.
Product
Clear Value Sugar, granulated, Net Wt. 4 lbs (1.81 kg), Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077.
Category
Food
Distribution
17 states
LowFDA (Food)·F-3266-2015·2015-10-07
Laura Lynn Pure Cane Sugar Recalled for Foreign Matter
Savannah-Imperial LP is recalling Laura Lynn Pure Cane Sugar because blue fiber was detected in the product.
Product
Laura Lynn, Pure Cane Sugar, Net Wt. 25 lbs (11.34 kg), Distributed by Ingles Markets, Inc., Asheville, NC 26816.
Category
Food
Distribution
17 states
LowFDA (Drugs)·D-0003-2016·2015-10-07
Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation
Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1831-2015·2015-10-07
VistaPharm Recalls Metoclopramide Oral Solution Due to Defective Container Lids
VistaPharm is recalling 84,100 cups of Metoclopramide Oral Solution because the unit dose cup lids are not fully qualified.
Product
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Category
Drug
Distribution
6 states
LowFDA (Drugs)·D-0004-2016·2015-10-07
Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation
Guthy-Renker LLC is recalling specific lots of Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0002-2016·2015-10-07
Rodan & Fields Proactiv Foundation Recalled for Subpotent Salicylic Acid
Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution compact foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D1834-2015·2015-10-07
Apotex Recalls Verapamil Hydrochloride Extended-Release Tablets for Dissolution Failure
Apotex Inc. is recalling 2,075 bottles of Verapamil Hydrochloride Extended-Release tablets, 240 mg, because one lot failed to meet dissolution specification limits.
Product
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-3263-2015·2015-10-07
Kroger Granulated Sugar Recalled for Foreign Matter Detection
Savannah-Imperial LP is recalling PSST Granulated Sugar distributed by Kroger due to the detection of blue fiber in the product.
Product
PSST, Granulated Sugar, Net Wt. 4 lbs (1.81 kg), Distributed by Kroger Co., Cincinnati, OH 45202.
Category
Food
Distribution
17 states
LowFDA (Devices)·Z-2806-2015·2015-09-30
Fujifilm EPX 2500 Processor Manual and Brochure Recall
Fujifilm is recalling EPX 2500 Processor manuals and brochures that incorrectly identify the ED-530XT endoscope's image quality.
Product
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2817-2015·2015-09-30
BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error
Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.
Product
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2810-2015·2015-09-30
Stryker Recalls Trident Hip Implant Components Due to Documentation Error
Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.
Product
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-1429-2015·2015-09-23
Akorn Recalls IC-Green Injection Kits Due to Low Potency
Akorn, Inc. is recalling 370 kits of IC-Green (indocyanine green for injection) because a low out-of-specification potency result was found.
Product
IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1)…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2764-2015·2015-09-23
Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals
Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.
Product
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits…
Category
Medical Device
Distribution
6 states
LowFDA (Drugs)·D-1430-2015·2015-09-23
Novartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure
Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.
Product
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-2779-2015·2015-09-23
Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect
Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.
Product
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
Category
Medical Device
Distribution
31 states
LowFDA (Devices)·Z-2773-2015·2015-09-23
Pointe Scientific Creatinine Reagent Recall Due to Labeling Error
Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.
Product
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
Category
Medical Device
Distribution
Distributed nationwide