The Recall Desk

State

Maine product recalls

72,984 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,894
Critical
468
Severe
791
Most recent
2026-09-02

Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5676–5700 of 76878

  • HighFDA (Drugs)·D-0586-2025·2025-08-20

    Sodium chloride injection containers recalled over potential fluid leakage at weld site

    B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0465-2025·2025-08-20

    La Michoacana variety paletas list cream without declaring milk as source

    La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.

    Product
    La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0462-2025·2025-08-20

    Cookies and cream paletas recalled because label lists cream without declaring milk

    La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.

    Product
    La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2025·2025-08-20

    Thyroglobulin assay reagent recalled after lot generated erroneously high patient results

    Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.

    Product
    Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0461-2025·2025-08-20

    Bubble gum paletas recalled because label lists cream without naming milk

    La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.

    Product
    La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0578-2025·2025-08-20

    Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level

    Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0467-2025·2025-08-20

    Rompope bolis 6-count packs recalled over cream ingredient missing milk source

    La Michoacana Rompope Bolis 6-Count 24 oz packs are recalled nationwide because the label lists cream but does not declare milk as its source. 11,274 units are affected.

    Product
    La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2025·2025-08-20

    Polyaxial screws in lot 8-4528 recalled over possible incorrect labeling

    PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2025·2025-08-20

    Surgical gauze rolls recalled over biological foreign matter and miscounted packs

    Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.

    Product
    Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2025·2025-08-20

    Custom manifold kit tubing may separate and trap air in line

    Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

    Product
    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0460-2025·2025-08-20

    Mango con crema paletas recalled for listing cream without milk allergen declaration

    La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.

    Product
    La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0471-2025·2025-08-20

    Choco-dipped mini paletas recalled because label lists cream but omits milk

    Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.

    Product
    Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0459-2025·2025-08-20

    La Michoacana strawberry paletas list cream without declaring milk as source

    La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.

    Product
    La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2025·2025-08-20

    EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling

    Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.

    Product
    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit

    Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2025·2025-08-20

    Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level

    Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.

    Product
    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0499-2025·2025-08-20

    Clover Valley instant coffee may contain glass pieces in jars

    Clover Valley Instant Coffee in 8 oz glass jars is being recalled because of the potential presence of glass pieces. 84,240 units are affected.

    Product
    Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·H-0469-2025·2025-08-20

    Helados Mexico variety paletas list cream without declaring milk as source

    Helados Mexico Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 42,488 units are affected.

    Product
    Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2025·2025-08-20

    Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output

    Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.

    Product
    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2025·2025-08-20

    Amlodipine and olmesartan tablets recalled after failing dissolution specification testing

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0425-2025·2025-08-20

    Dessert dip recalled nationwide after plastic foreign material found in product

    Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.

    Product
    Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2025·2025-08-20

    Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled

    PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.

    Product
    Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0464-2025·2025-08-20

    Strawberry con crema paleta 6-packs recalled for cream without milk declaration

    La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.

    Product
    La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2025·2025-08-20

    Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level

    Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.

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