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.

1576–1600 of 3531

ModerateFDA (Drugs)·D-0493-2023·2023-04-12
Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations
RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.
Product
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0524-2023·2023-04-12
Simvastatin Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
Product
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
ModerateCPSC·23176·2023-04-06
BISSELL Cordless Wet Dry Vacuums Recalled for Fire Hazard
BISSELL is recalling about 2,000 Cordless Multi-Surface Wet Dry Vacuums (models 2551R and 25518) because the battery pack circuit board can overheat and smoke, creating a fire hazard. No injuries have been reported.
Product
BISSELL® Cordless Multi-Surface Wet Dry Vacuums Models 2551R and 25518
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0482-2023·2023-04-05
Glimepiride tablet recall due to manufacturing practice deviations
Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.
Product
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0666-2023·2023-04-05
Seasoned Garlic with Salt and Vinegar recalled for ingredient statement update
Lemonland Food Corp recalled seasoned garlic distributed in Washington after providing consignees with an updated ingredients statement.
Product
Seasoned Garlic with Salt and Vinegar distributed in un-labeled plastic containers 6oz, 8oz, and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1301-2023·2023-04-05
PCRopsis Support Medical Device Recall Due to Misleading Label Statements
Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.
Product
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1307-2023·2023-04-05
ACL ELITE PRO analyzer test definition removal for Anti-Xa reagent
Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.
Product
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1317-2023·2023-04-05
Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers
A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.
Product
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1305-2023·2023-04-05
ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.
Product
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1297-2023·2023-04-05
PCRopsis Activator nucleic acid extraction kits recalled for misleading labels
Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.
Product
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0679-2023·2023-04-05
Cucumber Pickle Recalled for Ingredients Statement Correction
Lemonland Food Corp is recalling Cucumber Pickle in 8-ounce containers distributed in Washington from February 16–23, 2023, due to an incorrect ingredients statement. The firm provided an updated statement to consignees.
Product
Cucumber Pickle distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1296-2023·2023-04-05
PCRopsis Reagent Buccal Kit Recalled for Misleading Label Statements
Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.
Product
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2023·2023-04-05
Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations
Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.
Product
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2023·2023-04-05
Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations
Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.
Product
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0485-2023·2023-04-05
Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations
Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.
Product
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0477-2023·2023-04-05
Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations
Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.
Product
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0476-2023·2023-04-05
Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations
Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.
Product
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1295-2023·2023-04-05
PCRopsis BCSNano nucleic acid extraction kit recalled for misleading label statements
Entopsis, Inc. is recalling PCRopsis BCSNano nucleic acid extraction kits due to misleading statements on the product label. The affected lot (Lot 3, expiring 11/2023) was distributed nationwide and internationally.
Product
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0671-2023·2023-04-05
Rakkyo (scallions) recalled due to incorrect ingredients statement
Lemonland Food Corp recalled Rakkyo (scallions) distributed in Washington because the ingredients statement label required correction. The product contains no allergens.
Product
Rakkyo (scallions) distributed in un-labeled plastic containers 8oz and/or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1298-2023·2023-04-05
Medical device lysis beads recalled for misleading label statements
Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.
Product
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1299-2023·2023-04-05
PCR Reagent Recalled for Misleading Label Statements
Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.
Product
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1308-2023·2023-04-05
MicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
Product
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0478-2023·2023-04-05
Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations
Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.
Product
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0480-2023·2023-04-05
Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations
Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.
Product
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2023·2023-04-05
Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations
Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.
Product
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide