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Recalls affecting Puerto Rico

Data last updated: September 7, 2026 at 12:15 AM UTC

16,122 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 Men — dietary 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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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

Lipofit — Lipofit 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

Kofinas — Garlic 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 Temptations — Chocolatey 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 Sprouts — Robust 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

Martina — Mangoes

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)
NewestOldest
High riskLow riskAll
Wording
Class IHigh risk
DrugRecalled August 18, 2025

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

Presence of Particulate Matter.

ALL 50 STATES
▸Full report

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

Recall #:
D-0628-2025
Lot/product code:
Lot #: V3K770, Exp 1/31/2026
Recalling firm:
B BRAUN MEDICAL INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 18, 2025

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

Presence of Particulate Matter

ALL 50 STATES
▸Full report

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

Recall #:
D-0627-2025
Lot/product code:
Lot #: J4S807, Exp 5/31/2027
Recalling firm:
B BRAUN MEDICAL 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)
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.

ALARAZCACOCTDEFLGAHIIAIDILINKSLAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKPAPRSCSDTNTXUTVAWIWVWY
▸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 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
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
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 6, 2025

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.

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

ALL 50 STATES
▸Full report

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

Recall #:
D-0506-2025
Lot/product code:
All Lots.
Recalling firm:
Church & Dwight Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled June 4, 2025

Bornstein Frozen Shrimp Meat, Wild Caught - Product of USA. Product is cooked and Ready-To-Eat. Processed in the USA by Bornstein Seafoods Inc. Astoria, OR. The following items are being recalled: ZMU41-1003 Fzn Shrimp Meat 250/350 Ct 15 X 1lb. bag (net wt. 15lb) ZMU41-1007 Fzn Shrimp Meat 250/350 Ct 4 X 5lb. bag (net wt. 20lb) ZMU41-1015 Fzn Shrimp Meat 350/500 Ct 15 X 1lb. bag (net wt. 15lb) ZMU41-1019 Fzn Shrimp Meat 350/500 Ct 4 X 5lb bag (net wt. 20lb) ZMU41-1020 Fzn Shrimp Meat 350/500 Ct 20lb bag (net wt. 20lb) ZMU41-1045 Fzn Shrimp Meat 250/350 Ct 20lb bag (net wt. 20lb)

The recall was the result of the firm's routine sampling program and Listeria monocytogenes was detected in an in-process shrimp sample in a food production environment.

ALL 50 STATES
▸Full report

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

Recall #:
H-0069-2025
Lot/product code:
Item ZMU41-1003: Lot A19008 Item ZMU41-1007: Lot A18984, A19002, A19006, A19007, A19008, A19009, P11709, P11710, and P11714. Item ZMU41-1015: Lot A19009, A19019, A19026, A19030, A19032, A19037, and A19039. Item ZMU41-1019: Lot A18989, A19006, A19007, P11709, and P11710. Item ZMU41-1020: A19060 A19061 A19063 A19065 A19070 A19075 A19077 A19081 A19082 A19084 A19093 A19094 A19095 A19108 A19119 P11720 P11722 P11723 P11724 Item ZMU41-1045: A19030 A19032 A19033 A19037 A19039 A19060 A19063 A19064 A19065 A19068 A19069 A19070 A19075 A19076 A19082 A19084 A19094 A19108 P11709¿¿¿¿¿¿ P11722 P11724 P11730 Pl1723
Recalling firm:
Bornstein Seafoods Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 2, 2025

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

ALL 50 STATES
▸Full report

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

Recall #:
D-0488-2025
Lot/product code:
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Recalling firm:
Amneal Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled May 21, 2025

UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with not listed on the label ingredients: Dexamethasone, Diclofenac and Omeprazole.

ALL 50 STATES
▸Full report

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

Recall #:
D-0492-2025
Lot/product code:
All Lots; All Expiration Dates.
Recalling firm:
Umary-USA.com
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled May 21, 2025

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with not listed on the label ingredients: Dexamethasone and Diclofenac.

ALL 50 STATES
▸Full report

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

Recall #:
D-0493-2025
Lot/product code:
All Lots; All Expiration Dates.
Recalling firm:
Umary-USA.com
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled May 6, 2025

ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N

Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

ALL 50 STATES
▸Full report

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

Recall #:
D-0453-2025
Lot/product code:
Lot: 250214PRO, Expiration Date: 02/14/2027.
Recalling firm:
EnShiShiXiangNiShangMaoYouXianGongSi
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled April 17, 2025

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

Presence of Particulate Matter

ALL 50 STATES
▸Full report

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

Recall #:
D-0402-2025
Lot/product code:
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Recalling firm:
Amneal Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 14, 2025

ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

ALL 50 STATES
▸Full report

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

Recall #:
D-0465-2025
Lot/product code:
All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
Recalling firm:
SAINI TRADE INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 14, 2025

ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.

ALL 50 STATES
▸Full report

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

Recall #:
D-0466-2025
Lot/product code:
All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
Recalling firm:
SAINI TRADE INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 14, 2025

Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.

ALL 50 STATES
▸Full report

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

Recall #:
D-0467-2025
Lot/product code:
All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Recalling firm:
SAINI TRADE INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 14, 2025

MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.

ALL 50 STATES
▸Full report

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

Recall #:
D-0464-2025
Lot/product code:
All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
Recalling firm:
SAINI TRADE INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 14, 2025

Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.

Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.

ALL 50 STATES
▸Full report

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

Recall #:
D-0463-2025
Lot/product code:
All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027
Recalling firm:
SAINI TRADE INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 13, 2025

Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

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

Recall #:
D-0365-2025
Lot/product code:
Lot: A1540076, Exp 08/31/2026
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)