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Recalls affecting Alabama

Data last updated: September 7, 2026 at 2:36 PM UTC

16,706 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IHigh risk
DrugRecalled June 6, 2025

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0505-2025
Lot/product code:
All Lots.
Recalling firm:
Church & Dwight Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 6, 2025

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0504-2025
Lot/product code:
All lots.
Recalling firm:
Church & Dwight Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 27, 2025

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0569-2025
Lot/product code:
Lot # PG4360, PG4362, Exp. 11/30/2027
Recalling firm:
Sandoz Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 27, 2025

Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0570-2025
Lot/product code:
Lot # PG4360, PG4362, Exp. 11/30/2027
Recalling firm:
Sandoz Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled July 14, 2025

Dubai emek SPREAD PISTACHIO CACAO CREAM WITH KADAYIF NET WT. 9.7oz UPC 8 69652 10130 1 Manufacturer: Emek Dogal Saglik Urunlerilkl. Gida Turkey

Salmonella. The firm was notified by the FDA that the product may be contaminated with Salmonella.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0305-2025
Lot/product code:
BEST BEFORE: APRIL 01 2027; BATCH NUMBER: 250401
Recalling firm:
World Market Management Services, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2025

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0610-2025
Lot/product code:
Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
Recalling firm:
DermaRite Industries, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2025

PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0613-2025
Lot/product code:
Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
Recalling firm:
DermaRite Industries, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2025

DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0611-2025
Lot/product code:
Lot #: 40187.2, Exp. Date 2/2026
Recalling firm:
DermaRite Industries, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2025

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0612-2025
Lot/product code:
Lot #: 30705A, Exp. Date 8/2025; 30771A, Exp. Date 9/2025; 30920A, Exp. Date 10/2025; 40016A, Exp. Date 1/2026; 40303A, Exp. Date 4/2026; 40428A, Exp. Date 5/2026; 40505A, Exp. Date 6/2026; 41053C, 41053A, 41053B, Exp. Date 12/2026, 50017A, Exp. Date 1/2027.
Recalling firm:
DermaRite Industries, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Fresh Apple Bread Net Wt 23 oz (652g) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0506-2025
Lot/product code:
Product #1001 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Peach Fritter Net Weight 7 oz (198g) CONTAINS: Wheat, Soybeans, & Milk. Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0517-2025
Lot/product code:
Product #1052 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Strawberry Fritter Net Wt 7oz (198g) CONTAINS: Wheat, Soybeans, Milk. Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0519-2025
Lot/product code:
Product #1061 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Jalapeno Cheese Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0515-2025
Lot/product code:
Product #1018 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Cheese Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0512-2025
Lot/product code:
Product #1017 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Blueberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0510-2025
Lot/product code:
Product #1013 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Fresh Blackberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0509-2025
Lot/product code:
Product #1014 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Banana Nut Bread Net. Wt 23 oz (653g) CONTAINS: MILK, SOY, WHEAT & PECANSHILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0508-2025
Lot/product code:
Product #1016 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Strawberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, & WHEAT HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0518-2025
Lot/product code:
Product #1011 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Apple Fritter Contains: Wheat, Soy and Milk Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0507-2025
Lot/product code:
Product #1051 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Cinnamon Pecan Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0513-2025
Lot/product code:
Product #1012 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Blueberry Fritter Net Wt 7 oz (198g) CONTAINS: MILK, SOY, WHEAT. Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0511-2025
Lot/product code:
Product #1063 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Cinnamon Pecan Fritters Net Weight 7 oz (198g) CONTIANS: Wheat, Soybeans, Milk & Pecans Made By: Hillside Orchard Farms 105 Mitcham Circle Tiger, GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0514-2025
Lot/product code:
Product #1062 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenUndeclaredRecalled July 22, 2025

Fresh Peach Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, & WHEAT. HILLSIDE ORCHARD FARMS 105 Mitcham Circle, Tiger GA 30576

Not listed on the label egg.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0516-2025
Lot/product code:
Product #1002 Lot 24323-25197
Recalling firm:
Hillside Orchard Farms Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled July 25, 2025

Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g) BANANA POUCHES 5-0.25 OZ (10g) APPLE POUCHES NET WT 5.6OZ (160g) NO ADDED SWEETENERS ONE INGREDIENT ONLY PER PACK UPC 1 93968 50900 2

Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0394-2025
Lot/product code:
Best By: 06/24/2027 25175; Best By: 06/25/2027 25176; Best By: 06/26/2027 25177; Best By: 06/30/2027 25181; Best By: 07/01/2027 25182; Best By: 07/02/2027 25183; Best By: 07/03/2027 25184; Best By: 07/05/2027 25186; Best By: 07/07/2027 25188; Best By: 07/08/2027 25189; Best By: 07/09/2027 25190; Best By: 07/10/2027 25191; Best By: 07/11/2027 25192; Best By: 07/15/2027 25196; Best By: 07/16/2027 25197; Best By: 07/27/2027 25198; Best By: 07/18/2027 25199; Best By: 07/21/2027 25202; Best By: 07/22/2027 25203; Best By: 07/23/2027 25204; Best By: 07/24/2027 25205; Best By: 07/25/2027 25206
Recalling firm:
Doehler North America, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 30, 2025

NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

Microbial Contamination of Sterile Products: elevated endotoxin levels

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0094-2026
Lot/product code:
Lot#: GG121624-023, within expiry
Recalling firm:
GenoGenix LLC
View official FDA record (opens in a new tab)