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.

8376–8400 of 21595

ModerateFDA (Devices)·Z-2134-2019·2019-08-07
Hycor Biomedical Recalls AUTOSTAT II IgM Rheumatoid Factor Test Kits
Hycor Biomedical Inc is recalling 207 units of the AUTOSTAT II IgM Rheumatoid Factor test kit due to reports of higher than anticipated positivity rates, which may cause false positive results.
Product
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determina
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-1570-2019·2019-08-07
Wise Pharmacy Recalls Gentamicin Irrigation Solution Due to Processing Controls
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
Product
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Category
Drug
Distribution
3 states
ModerateFDA (Devices)·Z-2056-2019·2019-08-07
Agfa DR 800 Digital Radiography System Recalled for Image Mismatch
Agfa N.V. is recalling four DR 800 digital radiography systems because the exposed area of fluoroscopic exams may not match the active detector area.
Product
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1547-2019·2019-08-07
NingBo Huize Recalls Pink Lemonade Hand Gel for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling 20,160 units of Pink Lemonade Scented Antibacterial Hand Gel because stability testing was not conducted.
Product
AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2098-2019·2019-08-07
A&E Medical Ultra-Flex Pacing Wire Recalled for Instruction Updates
Alto Development Corp is recalling Ultra-Flex MYO/Wire pacing wires to update instructions for use to ensure consistency with the M-21 loop electrode.
Product
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopola
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1580-2019·2019-08-07
Pharma Pac Recalls Neomycin Ophthalmic Ointment for Quality Control Issues
Pharma Pac is recalling specific lots of Neomycin Ophthalmic Ointment due to insufficient quality assurance controls in the manufacturing facility.
Product
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1535-2019·2019-08-07
Tootsie Roll Antibacterial Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Orange Scented Antibacterial Hand Gel because stability testing was not conducted.
Product
Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-1714-2019·2019-07-31
Dannon Danimals Kids Yogurt Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Dannon Danimals Kids Yogurt sold at two New York Target stores because it was not held at the appropriate temperature during transportation.
Product
DANNON DANIMALS KIDS YOGURT COTTON CANDY - 6OZ, UPC: 3663201013
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1644-2019·2019-07-31
Chobani Black Cherry Greek Yogurt Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Chobani Black Cherry Greek Yogurt sold at two New York Target stores because it was not held at appropriate temperatures during transport.
Product
CHOBANI BLACK CHERRY ON THE BOTTOM NONFAT GREEK YOGURT - 5.3OZ/4PK, UPC: 1829001283
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1842-2019·2019-07-31
Pure Leaf Sweetened Lemon Iced Tea Recalled for Temperature Control Issues
C & S Wholesale Grocers is recalling Pure Leaf Sweetened Lemon Iced Tea sold at two New York Target stores because it was not held at an appropriate temperature during transportation.
Product
PURE LEAF SWEETENED LEMON ICED TEA - 59 FL OZ UPC: 4850002065
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1919-2019·2019-07-31
Simply Balanced Vanilla Almond Milk Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Simply Balanced Vanilla Almond Milk sold at two New York Target stores because it was not held at the appropriate temperature during transportation.
Product
VANILLA ALMONDMILK - 0.5GAL - SIMPLY BALANCED; UPC: 8523960123
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1813-2019·2019-07-31
Mini Babybel Light Semisoft Cheeses Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Mini Babybel Light Semisoft Cheeses sold at two Target stores in New York because they were not held at appropriate temperatures during transport.
Product
MINI BABYBEL LIGHT SEMISOFT CHEESES - 14CT 94 UPC: 4175731381
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1830-2019·2019-07-31
Oscar Mayer Lunchable Pizza Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Oscar Mayer Lunchable Extra Cheesy Pizza sold at two Target stores in New York because the product was not held at an appropriate temperature during transportation.
Product
OSCAR MAYER LUNCHABLE EXTRA CHEESY PIZZA - 4.2OZ UPC: 4470002411
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1612-2019·2019-07-31
C & S Wholesale Grocers Recalls Tropical Lime Salad Due to Temperature Issues
C & S Wholesale Grocers is recalling Eat Smart Salad Tropical Lime sold at two Target stores in New York because the product was not held at appropriate temperatures during transportation.
Product
EAT SMART SALAD TROPICAL LIME - 5.5OZ, UPC: 0935130179
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1768-2019·2019-07-31
Hershey's Chocolate Pudding Recalled Due to Temperature Control Failure
C & S Wholesale Grocers is recalling Hershey's Chocolate Pudding sold at two New York Target stores because the product was not held at an appropriate temperature during transportation.
Product
HERSHEY'S CHOCOLATE PUDDING - 4PK/3.875OZ CUPS UPC: 4300006730
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1634-2019·2019-07-31
Blue Diamond Almond Breeze Almondmilk Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Blue Diamond Almond Breeze Almondmilk sold at two New York Target stores because the product was not held at an appropriate temperature during transportation.
Product
BLUE DIAMOND ALMOND BREEZE ALMONDMILK - 0.5GAL UPC:4157005670
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1764-2019·2019-07-31
Market Pantry Grade A Large Eggs Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Market Pantry Grade A Large Eggs sold at two Target stores in New York due to a mechanical malfunction that prevented proper temperature control during transportation.
Product
GRADE A LARGE EGGS - 18CT - MARKET PANTRY; UPC: 8523931158
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-1492-2019·2019-07-31
Pharma-Natural Recalls Oliver's Harvest CBD+Capsaicin Cream for CGMP Violations
Pharma-Natural Inc. is recalling 998 bottles of Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief Cream due to current good manufacturing practice violations.
Product
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1776-2019·2019-07-31
Horizon Organic Skim Milk Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Horizon Organic Skim Milk sold at two New York Target stores because it was not held at an appropriate temperature during transportation.
Product
HORIZON ORGANIC SKIM MILK - 0.5GAL UPC: 4236526405
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1636-2019·2019-07-31
Blue Diamond Almond Breeze Almond Milk Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Blue Diamond Almond Breeze Unsweetened Vanilla Almondmilk sold at two New York Target stores because it was not held at appropriate temperatures during transport.
Product
BLUE DIAMOND ALMOND BREEZE UNSWEETENED VANILLA ALMONDMILK - 0.5GAL, UPC: 4157005618
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1704-2019·2019-07-31
Daisy Sour Cream Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Daisy Pure & Natural Sour Cream sold at two New York Target stores because it was not held at the appropriate temperature during transportation.
Product
DAISY PURE & NATURAL SOUR CREAM - 16OZ, UFC: 7342000011
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1936-2019·2019-07-31
Yoplait Strawberry Banana Yogurt Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Yoplait Original Strawberry Banana Yogurt because it was not held at the appropriate temperature during transportation.
Product
YOPLAIT ORIGINAL STRAWBERRY BANANA YOGURT - 6OZ UPC: 7047000313
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1696-2019·2019-07-31
Coffee Mate Almondmilk Creamer Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Coffee Mate Natural Bliss Vanilla Almondmilk Coffee Creamer sold at two New York Target stores because it was not held at the appropriate temperature during transportation.
Product
COFFEE MATE NATURAL BLISS VANILLA ALMONDMILK COFFEE CREAMER - 1PT, UPC: 5000046786
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1712-2019·2019-07-31
Dannon Activia Vanilla Probiotic Yogurt Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Dannon Activia Vanilla Probiotic Yogurt sold at two Target stores in New York due to a mechanical malfunction that caused improper temperature control during transportation.
Product
DANNON ACTIVIA VANILLA PROBIOTIC YOGURT - 4OZ UPC:3663202601
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1905-2019·2019-07-31
Tropicana Orange Juice Recalled for Temperature Control Failure
C & S Wholesale Grocers is recalling Tropicana Grab and Go orange juice sold at two Target stores in New York due to a mechanical malfunction that prevented proper temperature control during transportation.
Product
TROPICANA GRAB AND GO NO PULP CALCIUM & VITAMIN D 100% PURE ORANGE JUICE - 6PK/8 FL OZ CARTONS UPC: 4850000820
Category
Food
Distribution
1 state