State

Arkansas product recalls

72,982 recalls have nationwide distribution and so reach Arkansas. 5,513 additional recalls listed Arkansas specifically in their distribution scope.

What the numbers show

Total: 5,513
Critical: 1,018
Severe: 1,210
Most recent: 2026-09-09

Of the 5,513 recalls naming Arkansas we have scored against our rubric, 1,018 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,210 (22%) are Severe.

Which agencies issued them

These figures cover only the 5,513 recalls whose distribution notice names Arkansas specifically. The 72,982 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5851–5875 of 78495

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-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-0449-2025·2025-08-20
Sukhi's classic curry paste may contain metal foreign objects
Sukhi's Classic Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 5,030 pounds are affected.
Product
Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Category
Food
Distribution
33 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 (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 (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 (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 (Devices)·Z-2278-2025·2025-08-20
FARAWAVE ablation catheters may have cracks in the distal electrode bands
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Category
Medical Device
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
HighFDA (Devices)·Z-2285-2025·2025-08-20
Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, 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, 4L 16MM, VE Model/Catalog Number: 341-16-704 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 (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 (Food)·H-0468-2025·2025-08-20
Mini variety paletas recalled because label lists cream without declaring milk
Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.
Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
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-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 (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 (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 (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 (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
ModerateFDA (Devices)·Z-2321-2025·2025-08-20
Medication dispensing cabinets recalled after reports of delayed access during override workflow
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
Product
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0584-2025·2025-08-20
Belsomra 10 mg tablets failed dissolution, which may delay sleep onset
Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.
Product
BELSOMRA — BELSOMRA (SUVOREXANT)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0445-2025·2025-08-20
Lithium orotate 10 mg product recalled for failing labeled potency standard
Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2289-2025·2025-08-20
Plastic trial heads carry inconsistent size terminology and color coding
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2298-2025·2025-08-20
Ultra IABP catheter kits carry indications not reviewed by the FDA
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
Product
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
Category
Medical Device
Distribution
Distributed nationwide