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.

3076–3100 of 3531

ModerateFDA (Drugs)·D-0277-2022·2021-12-15
Apollo Care VANComycin Injection Recalled for Crystallization
Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.
Product
VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0271-2022·2021-12-15
Antihistamine and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0276-2022·2021-12-15
Hydrocodone Bitartrate and Acetaminophen tablets recalled for product mix-up
Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg tablets nationwide due to a product mix-up. The recall affects 9,744 bottles and was voluntarily initiated by the manufacturer.
Product
HYDROCODONE BITARTRATE AND ACETAMINOPHEN — HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0274-2022·2021-12-15
Walmart Allergy Relief D Extended-Release Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.
Product
Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0270-2022·2021-12-15
Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
Category
Drug
Distribution
Distributed nationwide
ModerateNHTSA·20V584000·2021-12-09
2021 International MV and HV trucks missing required reflective tape
Navistar is recalling 2021 International MV and HV trucks that may lack reflective tape on the cab, required by federal safety standards. Without it, trucks are less visible at night, increasing crash risk.
Product
INTERNATIONAL — 2021 INTERNATIONAL MV
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·20V586000·2021-12-09
Incorrect Tire Pressure Labels on 2020-2021 Land Rover Range Rover Sport
Certain 2020-2021 Land Rover Range Rover Sport vehicles with 19-inch wheels have incorrect tire pressure information on their labeling. This could lead to improper tire inflation and loss of vehicle control.
Product
LAND ROVER — 2020 LAND ROVER RANGE ROVER SPORT
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0235-2022·2021-12-08
Tastykake Chocolate Creme Filled Cupcakes Recalled for Metal Fragments
Flowers Foods is recalling Tastykake Chocolate Creme Filled Cupcakes due to the potential presence of small metal fragments in an ingredient. The affected product has an "Enjoy By" date of December 14 or December 18.
Product
Tastykake Chocolate Creme Filled Cupcakes 14.25oz, UPC 0 25600 00223 0
Category
Food
Distribution
37 states
ModerateFDA (Food)·F-0263-2022·2021-12-08
Teg Creme Cake Bags Recalled for Potential Metal Contamination
Puratos Corporation is recalling Teg Creme Cake Bags (50 lb) because they may contain foreign metal material. The affected product was distributed to customers in multiple U.S. states and internationally.
Product
Teg Creme Cake Bag 50#. Material #4107664
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-0319-2022·2021-12-08
NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection
NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.
Product
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1
Category
Medical Device
Distribution
46 states
ModerateFDA (Food)·F-0265-2022·2021-12-08
Teg Moist'r Yellow Layer Cake Mix Recalled for Metal Contamination
Puratos Corporation is recalling Teg Moist'r Yellow Layer Cake Mix (50# bag, Batch Number 10737143) due to potential metal contamination. The product was distributed to customers across 12 U.S. states and 2 foreign countries.
Product
Teg Moist'r Yellow Layer Cake Bag 50# Material #4107439
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-0313-2022·2021-12-08
Orthopedic implant hip component recalled in Puerto Rico
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0254-2022·2021-12-08
Easy Satin Supreme Creme Cake Bag contaminated with metal
Puratos Corporation is recalling Easy Satin Supreme Creme Cake Bag 50# due to potential metal contamination. The affected product was distributed to bakery and food manufacturers in twelve U.S. states and two Caribbean countries.
Product
Easy Satin Supreme Creme Cake Bag 50#. Material #4107808
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-0310-2022·2021-12-08
Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls
DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Category
Medical Device
Distribution
3 states
ModerateFDA (Food)·F-0248-2022·2021-12-08
TK006 Van Krimpet Powder Blend recalled for metal contamination
Puratos Corporation is recalling TK006 Van Krimpet Powder Blend (50 lb bags, item number 4107780) because the product may contain foreign metal material. The affected batches are 0010636568 and 1110644921.
Product
TK006 Van Krimpet Powder Blend 50#. Item number 4107780
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-0311-2022·2021-12-08
Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label
Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.
Product
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable
Category
Medical Device
Distribution
4 states
ModerateFDA (Food)·F-0249-2022·2021-12-08
Puratos TK019 Chocolate Powder Blend Recalled for Metal Contamination
Puratos Corporation is recalling approximately 119,900 lbs of TK019 2017 Choc Cup Powder Blend due to potential metal contamination. Affected batch numbers are 0010636571 and 0010636577.
Product
TK019 2017 Choc Cup Powder Blend Bag 50#. Item number 4005543
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-0212-2022·2021-12-01
Garden Side Salad recalled for potential plastic fragments
Ukrop's Homestyle Foods is recalling Garden Side Salad 6.95oz containers due to possible contamination with plastic fragments. The product was distributed to retail stores across six states.
Product
Garden Side Salad 6.95oz. (197g) UPC:72251525202. Packaged in plastic containers.
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-0298-2022·2021-12-01
Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
Product
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2022·2021-12-01
Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.
Product
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0216-2022·2021-12-01
Mr. Special Jugo de Pina Concentrated Pineapple Juice Recalled for Swollen Cans
Empresas La Famosa, Inc. is recalling Mr. Special Jugo de Pina De Concentrado 46 oz cans due to swollen cans discovered during production. The recall affects 409 cases distributed in Puerto Rico.
Product
Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans per case of 46 oz each
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0275-2022·2021-12-01
da Vinci Surgical Drapes Recalled for Incorrect Expiration Date on Packaging
Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.
Product
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instru
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0284-2022·2021-12-01
CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays
A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.
Product
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0303-2022·2021-12-01
Siemens Artis Q.zen Angiography System May Fail to Fire X-rays During Simultaneous Operations
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Product
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0297-2022·2021-12-01
Siemens Artis zee x-ray system may delay imaging delivery during procedures
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Product
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Category
Medical Device
Distribution
Distributed nationwide