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.

2126–2150 of 3531

ModerateFDA (Food)·F-1734-2022·2022-09-21
GNC Vitamin B-6 supplement mislabeled; bottles contain Pycnogenol instead
GNC Vitamin B-6 100mg dietary supplement bottles actually contain Pycnogenol due to a filling line error. The product was distributed across all 50 US states and multiple international locations.
Product
GNC Vitamin B-6 100mg 100 VEGETARIAN TABLETS DIETARY SUPPLEMENTS Distributed by: General Nutrition Corporation Pittsburgh, PA 15222 UPC 0 48107 20584 3
Category
Food
Distribution
0 states
ModerateFDA (Drugs)·D-1512-2022·2022-09-21
FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations
Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed nationwide and internationally.
Product
CITROMA — CITROMA (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1736-2022·2022-09-21
Steris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators
Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.
Product
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Category
Medical Device
Distribution
31 states
ModerateFDA (Drugs)·D-1513-2022·2022-09-21
Magnesium Citrate Saline Laxative Recalled for Manufacturing Deviations
Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.
Product
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1511-2022·2022-09-21
OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations
Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.
Product
CITROMA — CITROMA (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1735-2022·2022-09-21
Stryker USB Converter in Mako Robotic Surgery System May Fail
Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.
Product
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1733-2022·2022-09-21
GXL Hip Implant Liners Recalled for Packaging Defect Risk
Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1729-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, RE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1483-2022·2022-09-14
Magnesium Hydroxide and Aluminum Hydroxide Oral Suspension Recalled for Manufacturing Control Issues
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1485-2022·2022-09-14
Acetaminophen Oral Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Product
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1697-2022·2022-09-14
Orange creme cake recalled for undeclared soy allergen
Select Bakery's 3-oz Orange Creme Cake is recalled for undeclared soy. The product was voluntarily recalled and distributed to Georgia, North Carolina, and South Carolina.
Product
Select Bakery Old Fashion Orange Creme Cake Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10005 6
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1688-2022·2022-09-14
Thick-It Food & Beverage Thickener recalled for insanitary manufacturing conditions
Kent Precision Foods Group is recalling Thick-It Original Food & Beverage Thickener due to possible insanitary conditions during manufacturing. The product was distributed to food service facilities including hospitals and nursing homes.
Product
Thick-It Original Food & Beverage Thickener 6/36 oz. jars per case
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1696-2022·2022-09-14
Select Bakery Old Fashion Chocolate Creme Cake recalled for undeclared soy
Select Bakery has recalled its Old Fashion Chocolate Creme Cake for containing undeclared soy. The recall affects products distributed in Georgia, North Carolina, and South Carolina.
Product
Select Bakery Old Fashion CHOCOLATE CREME Cake Net Wt. 3 Oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10010 0
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-1482-2022·2022-09-14
Antacid Suspension Recalled Due to Manufacturing Process Control Deviations
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1481-2022·2022-09-14
Milk of Magnesia Recalled for Manufacturing Process Control Issues
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
Category
Drug
Distribution
Distributed nationwide
ModerateCPSC·22770·2022-09-08
Tethrd One Stick GEN 2 Climbing Sticks Recalled Due to Fall Hazard
About 7,700 Tethrd One Stick GEN 2 climbing sticks are being recalled because their steps can crack and break under pressure, creating fall and injury hazards. The manufacturer has received five reports of step breakage but no injuries have been reported.
Product
Tethrd One Stick GEN 2 Climbing Sticks
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22218·2022-09-08
Roots & Harvest Wide Mouth Pint Canning Jars Recalled for Laceration Hazard
LEM Products Distribution is recalling about 15,900 Roots & Harvest Wide Mouth Pint Canning Jars because pieces of glass may be found inside, posing a laceration hazard. No injuries have been reported.
Product
Roots & Harvest Wide Mouth Pint Canning Jars
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22217·2022-09-08
Children's HearMuffs Recalled Due to Rupturing Battery Hazard
Hearing Lab Technology/Lucid Audio is recalling approximately 31,150 Children's HearMuffs sound compression ear muffs because the AAA alkaline batteries included can rupture, posing hearing, projectile, and burn injury risks. No injuries have been reported.
Product
Children's HearMuffs sound compression ear muffs
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2022·2022-09-07
X-ray imaging system hardware defect may prevent operation
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
Product
Artis pheno- Model No. 10849000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1470-2022·2022-09-07
Colgate OPTIC WHITE Mouthwash Recalled Due to Improper Storage Conditions
Family Dollar is recalling Colgate Whitening Mouthwash OPTIC WHITE ICY FRESH MINT due to temperature storage deviations. 840 packages were distributed to Family Dollar stores in multiple states.
Product
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1466-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste recalled for improper storage conditions
Colgate Anticavity Fluoride Toothpaste, Optic White Renewal was recalled after being stored outside appropriate temperature conditions. The recall affects 840 packages distributed to Family Dollar stores in 11 states.
Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1678-2022·2022-09-07
Frozen Lentil Soup Recalled for Undeclared Wheat Allergen
Yem Foods LLC is recalling Priyems Sambar Spicy Lentil Soup for containing undeclared wheat starch in an ingredient. Consumers with wheat allergies should not consume this product.
Product
Priyems Sambar Spicy Lentil Soup 800 grams (1.76 lbs) UPC 8 61754 00010 0, 8 retail units per wholesale case, Frozen
Category
Food
Distribution
15 states
ModerateFDA (Devices)·Z-1668-2022·2022-09-07
DeRoyal Sterile Custom Kits Recalled for Defective Connectors
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.
Product
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1469-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste Recalled Due to Improper Storage Conditions
Family Dollar Stores recalls 1,400 packages of Colgate Anticavity Fluoride Toothpaste due to improper temperature storage conditions during manufacturing. The product may not meet quality standards.
Product
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1474-2022·2022-09-07
Isopropyl Alcohol Product Contains Undeclared Ethyl Alcohol
Luxury 70% Isopropyl Alcohol distributed in Virginia by TSM Brands LLC contains undeclared ethyl alcohol, creating a mislabeling hazard. Consumers should stop using the product.
Product
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Category
Drug
Distribution
1 state