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 2769

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-0016-2016·2015-10-21
Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
Tribute Pharmaceuticals is recalling specific lots of Fenofibric Acid Tablets because they may contain trace amounts of benzophenone from label varnish.
Product
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIB
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0017-2016·2015-10-21
Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
Tribute Pharmaceuticals is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg because they may contain trace amounts of benzophenone from label varnish.
Product
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, I
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0035-2016·2015-10-21
TopCare Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling TopCare Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Vill
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0022-2016·2015-10-21
Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed
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 (Drugs)·D-0037-2016·2015-10-21
Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
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-0023-2016·2015-10-21
CVS Loratadine Tablets Recalled for Out-of-Specification Assay Results
CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.
Product
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. On
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0026-2016·2015-10-21
Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.
Product
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
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 (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-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-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 (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-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-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 (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-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 (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-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-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-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 (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