The Recall Desk

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.

3501–3525 of 21589

  • ModerateFDA (Drugs)·D-0757-2023·2023-05-31

    Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations

    Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.

    Product
    Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1615-2023·2023-05-31

    ViziShot 2 Aspiration Needle recalled for manufacturing angle defect

    ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.

    Product
    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0759-2023·2023-05-31

    Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations

    Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0940-2023·2023-05-31

    Dietary Supplement TruCONTROL Recalled Due to Unapproved Ingredients

    TruVision Health's truCONTROL 60 Count dietary supplement is being recalled because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.

    Product
    truCONTROL 60 Count
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·F-0943-2023·2023-05-31

    Dietary supplement recalled for containing unapproved ingredients

    TruVision Health LLC is recalling truControl W/Dynamine because the product contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.

    Product
    truControl W/Dynamine 60 ct
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-1479-2023·2023-05-31

    Fluoroscopic imaging system may display incorrect radiation dose readings

    Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.

    Product
    Luminos Agile Max (VE10, VF10, VF11)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1632-2023·2023-05-31

    Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias

    Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.

    Product
    Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23762·2023-05-25

    The Good and the Beautiful Math Boxes Recalled Due to Laceration Hazard

    The Good and the Beautiful is recalling Math 1 and Math 3 boxes with metallic whiteboards because the attached whiteboards can detach and cause lacerations. Four minor laceration injuries have been reported.

    Product
    The Good and the Beautiful Math 1 and Math 3 Boxes with metallic whiteboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2023·2023-05-24

    Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

    RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

    Product
    Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1604-2023·2023-05-24

    Dental implant system recalled for incorrect package length labeling

    Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.

    Product
    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2023·2023-05-24

    3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk

    3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.

    Product
    3M Attest Steam Chemical Integrators, REF 1243B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0888-2023·2023-05-24

    Wakame Seaweed Salad recalled for undeclared wheat allergen

    Origami Catering's Wakame Seaweed Salad is recalled because wheat is present but not declared in the allergen statement. Affected product: 4.5oz packages, UPC 8 51016 00235 5, distributed in Oregon and Washington.

    Product
    Wakame Seaweed Salad, ready to eat product. Net Weight: 4.5oz 127g. UPC 8 51016 00235 5. Label Ingredients declares: Seaweed (Wakame), Agar Agar ***, Sesame Seeds, Sesame Oil,***Soy Sauce ( Soy, Wheat***)*** Contains Soy, Sesame***". UPC: 8 51016 00235 5. Manufactured by Origam
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0647-2023·2023-05-24

    Vancomycin IV Injection Recalled for Lack of Sterility Assurance

    Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.

    Product
    VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23206·2023-05-18

    Kell Electronic Personal Chiller Mini Refrigerators Recalled for Burn Hazard

    Kell Electronic is recalling about 25,000 Personal Chiller Mini Fridge Gamer Beverage Refrigerators with LED Lights because the power cord can overheat and cause burns. No injuries have been reported.

    Product
    Personal Chiller Mini Fridge Gamer Beverage Refrigerators with LED Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23758·2023-05-18

    Cole & Mason Pepper Mills Recalled for Metal Shard Laceration Hazard

    DKB Household is recalling Cole & Mason 505WEG Pepper Mills due to a metal grinding mechanism that sheds metal shards during initial use, posing a laceration risk. No injuries have been reported.

    Product
    Cole & Mason 505WEG Pepper Mills Item Number H50501PWE
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23757·2023-05-18

    Shimano PRO Vibe Alloy Bicycle Stems Recalled for Crack and Injury Risk

    Shimano is recalling about 400 PRO Vibe Alloy stems for road bicycles because the stems can crack and break during use, causing loss of control and crash risk. Two reports of cracking have been received in the U.S., but no injuries have been reported.

    Product
    Shimano PRO Vibe Alloy stems for road bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0862-2023·2023-05-17

    Takuma food dashi salt peanut recalled for incorrect fish ingredient

    Takuma food dashi salt peanut 80g is being recalled because the product contains flying fish instead of angler fish. Consumers who purchased this product should stop using it.

    Product
    Takuma food dashi salt peanut 80g UPC: 4962679652750
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0870-2023·2023-05-17

    Wadakan Sukiyaki Sauce Recalled Due to Incomplete Fish Species Labeling

    Daiso California Warehouse is recalling Wadakan sukiyaki sauce due to incomplete allergen labeling. The product lists fish in the ingredients and contains statement but does not specify the fish species.

    Product
    Wadakan sukiyaki sauce 300ml UPC: 4903636311594
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0881-2023·2023-05-17

    Food recall: Smoked Mahi Dip undeclared Yellow #5 additive

    Borris Brothers voluntarily recalled Smoked Mahi Dip (8oz and 48oz) in Florida due to undeclared Yellow #5 food dye. Consumers sensitive to this color additive should not consume the product.

    Product
    Smoked Mahi Dip, Net Wt. 8oz and 48oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0570-2023·2023-05-17

    Gabapentin tablets recalled due to product mixup with foreign tablet

    The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide