State

Alabama product recalls

72,984 recalls have nationwide distribution and so reach Alabama. 6,341 additional recalls listed Alabama specifically in their distribution scope.

What the numbers show

Total: 6,341
Critical: 1,121
Severe: 1,337
Most recent: 2026-09-02

Of the 6,341 recalls naming Alabama we have scored against our rubric, 1,121 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,337 (21%) are Severe.

Which agencies issued them

These figures cover only the 6,341 recalls whose distribution notice names Alabama specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5851–5875 of 79325

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-0470-2025·2025-08-20
Helados Mexico choco dipped paletas list cream without declaring milk
Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.
Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
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 (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 (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 (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-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-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-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-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 (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 (Devices)·Z-2281-2025·2025-08-20
Kittner and tail gauze rolls had biological foreign matter inside packaging
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0588-2025·2025-08-20
Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2025·2025-08-20
Custom tubing kits recalled because high pressure tubing may trap air
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
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 (Devices)·Z-2296-2025·2025-08-20
Custom waste management kit tubing may trap air in the line
Custom Waste Management 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. 858 units affected.
Product
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0458-2025·2025-08-20
Single serve coconut con crema paletas recalled for missing milk source declaration
La Michoacana Coconut Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 74,654 units are affected.
Product
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Category
Food
Distribution
Distributed nationwide
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 (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 (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-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-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 (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