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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)

Recalls nationwide

Data last updated: September 9, 2026 at 1:18 PM UTC

19,424 recalls found
Wording
Class IIModerate risk
FoodRecalled July 25, 2025

La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0458-2025
Lot/product code:
Best By Date: 10/3/2026 - 5/3/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 25, 2025

La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0465-2025
Lot/product code:
Best By Date: 9/9/2026 - 4/12/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 25, 2025

La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0466-2025
Lot/product code:
Best By Date: 3/14/2027 and 3/16/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 25, 2025

La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0463-2025
Lot/product code:
Best By Date: 11/25/2026 - 4/12/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 25, 2025

Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0469-2025
Lot/product code:
Best By Date: 12/31/2026 - 5/2/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 25, 2025

Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7

Product label includes the ingredient CREAM but does not include Milk as the source.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0471-2025
Lot/product code:
Best By Date: 1/14/2027 - 6/18/2027
Recalling firm:
Tropicale Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenMilkSoyWheatUndeclaredRecalled July 24, 2025

Chocolate Croissants --- Ingredients: HARVEST KING FLOUR, Butter, Water, Sugar, Yeast, Salt, Chocolate Chips (Sugar, Chocolate, Butter

Not listed on the label wheat, milk, and soy (from soy lecithin) from sub-ingredients.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0491-2025
Lot/product code:
USE BY: 7/20/25 through 7/20/26
Recalling firm:
The Bonami Baking Company, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenMilkSoyUndeclaredRecalled July 24, 2025

Whole Wheat Chocolate Croissants --- Ingredients: Whole White Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamine Mononitrate (Vitamin B1), Riboflavin, Folid Acid) Water, Sugar, Dried Whey, Salt, Yeast, Chocolate Chips (Sugar, Chocolate, Cocoa Butter, Milkfat, Soy Lecithin, Vanillin, Artificial Flavor, Milk) --- Contains: MILK, WHEAT --- FROZEN --- Net weight: 27.00 LBS. (3 oz./144 Count)144/cs --- Produced by The Bonami Baking Company

Not listed on the label milk and soy (from soy lecithin) from sub-ingredients.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0488-2025
Lot/product code:
USE BY: 7/20/25 through 7/20/26
Recalling firm:
The Bonami Baking Company, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenMilkUndeclaredRecalled July 24, 2025

Whole Grain Par Baked Jalapeno Cheddar Bagel --- Ingredient Declaration: Whole White Wheat Flour, Enriched Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamine Mononitrate (Vitamin B1), Riboflavin (Vitamin B2), Folic Acid) Water, Brown Sugar, Malt Extract, Salt, Yeast, Cheddar Cheese (Pasteurized Cultured Milk, Salt, Enzymes, Annatto Color), Jalapeno --- Contains Allergen: Wheat --- Keep Frozen --- Net weight: 15.3 LBS. (3 oz./72 Count) --- Produced by The Bonami Baking Company

Not listed on the label milk from Contains statement.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0487-2025
Lot/product code:
USE BY: 7/20/25 through 7/20/26
Recalling firm:
The Bonami Baking Company, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenMilkWheatUndeclaredRecalled July 24, 2025

Cheddar Bagel --- Ingredient Declaration: Harvest King Flour, All purpose flour, kosher salt, light brown sugar, yeast, water, malt, cheddar cheese --- The Bonami Baking Company

Not listed on the label wheat and milk from sub-ingredients.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0490-2025
Lot/product code:
USE BY: 7/20/25 through 7/20/26
Recalling firm:
The Bonami Baking Company, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenMilkUndeclaredRecalled July 24, 2025

Wheat Hamburger Buns --- Ingredient Declaration: Water, Whole Wheat Flour, Enriched Wheat Flour (Unbleached Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate (Vitamin B1) Riboflavin (Vitamin B2), Folic Acid) Eggs, Butter (Pasteurized Cream, Natural Flavorings), Sugar, Water, Dried Whey, Salt, Yeast --- Contains Allergen: Wheat --- Heating Instructions: Remove Buns from freezer and defrost in refrigerator. Serve at room temperature or toast bun for 3-5 minutes in 350-degree oven for optimal flavor. --- Net weight: 27.00 LBS. (12 ct / 12 pkgs) --- The Bonami Baking Co.

Not listed on the label milk and/or eggs from sub-ingredients and/or Contains statement.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-0489-2025
Lot/product code:
USE BY: 7/20/25 through 7/20/26
Recalling firm:
The Bonami Baking Company, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 22, 2025

BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01

Not guaranteed to be germ-free.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0589-2025
Lot/product code:
Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Recalling firm:
Taizhou Kangping Medical Science And Technology Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 22, 2025

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Failed Impurities/Degradation Specifications: An not meeting quality requirements for total related compounds

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0551-2025
Lot/product code:
Lot # K24118, exp. date 10/31/2026
Recalling firm:
Hikma Pharmaceuticals USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 21, 2025

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

Failed Dissolution Specifications: low dissolution results

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0576-2025
Lot/product code:
Lot 23121560, Exp 4/30/2026
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 21, 2025

Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0584-2025
Lot/product code:
Lots 2090019 and 2123744, Exp. 4/30/2027
Recalling firm:
Merck & Co. Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 21, 2025

Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.

CGMP Deviations

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0659-2025
Lot/product code:
Lot #: 20240610, Exp. Date 06/2029
Recalling firm:
YANGZHOU YULOU PAPER PRODUCTS CO., LTD
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0558-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0555-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0562-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0553-2025
Lot/product code:
All Lots within expiry
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0563-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0556-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0557-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0559-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 18, 2025

Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

Lack of Processing Controls.

Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0564-2025
Lot/product code:
All Lots within expiry.
Recalling firm:
AEQUITA PHARMACY
View official FDA record (opens in a new tab)