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.

3601–3625 of 21589

ModerateFDA (Drugs)·D-0512-2023·2023-04-12
Atorvastatin Calcium Tablets 20 mg Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.
Product
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1320-2023·2023-04-12
Biosense Webster guiding sheath recalled for labeling mismatch
Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0519-2023·2023-04-12
Rosuvastatin Calcium Tablets Recalled for Manufacturing Deviations
Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.
Product
ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0490-2023·2023-04-12
Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.
Product
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2023·2023-04-12
Prescription Tadalafil tablets recalled for manufacturing process deviations
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2023·2023-04-12
Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns
Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.
Product
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2023·2023-04-12
Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations
RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0516-2023·2023-04-12
Finasteride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.
Product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0509-2023·2023-04-12
Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.
Product
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2023·2023-04-12
Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.
Product
Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0528-2023·2023-04-12
Cyanocobalamin injection vials recalled for failing potency tests
Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.
Product
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Dur
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2023·2023-04-12
Glimepiride Tablets Recall Due to Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2023·2023-04-12
Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations
RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.
Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2023·2023-04-12
Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
Product
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
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-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
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-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 (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
1 state
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 (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-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-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-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 (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