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Recalls affecting Kentucky

Data last updated: September 8, 2026 at 1:13 PM UTC

16,694 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 IIModerate risk
DrugRecalled December 31, 2025

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

Not guaranteed to be germ-free: Products have not been manufactured in conformance with current good manufacturing practices.

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-0351-2026
Lot/product code:
All lots
Recalling firm:
Wizcure Pharmaa Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2025

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.

Not guaranteed to be germ-free: Products have not been manufactured in conformance with current good manufacturing practices.

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-0347-2026
Lot/product code:
All lots
Recalling firm:
Wizcure Pharmaa Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2025

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

Not meeting quality requirements for dissolution.

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-0292-2026
Lot/product code:
Lot #49124, Exp Date 12/31/2026
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2025

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

Not guaranteed to be germ-free: Products have not been manufactured in conformance with current good manufacturing practices.

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-0350-2026
Lot/product code:
All lots
Recalling firm:
Wizcure Pharmaa Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2025

Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

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-0259-2026
Lot/product code:
Lot # MHA21825, Exp Date: December 31, 2027
Recalling firm:
Alvogen, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 30, 2025

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07

Weaker than it should be Drug: Due to oxidation caused by leakage of the contents of the capsules

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-0295-2026
Lot/product code:
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 30, 2025

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

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-0246-2026
Lot/product code:
Lot #: 19251311, Exp Date April 2027
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 30, 2025

CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)

Hard corn starch lumps were found in the product

FLILINKYMNNCOHPATNVAWI
▸Full report

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

Recall #:
H-0667-2026
Lot/product code:
Case/UPC 1 00 44000 08667 8 Best When Used By Dates 09MAY2026 10MAY2026 11MAY2026 12MAY2026 Case/UPC 1 00 44000 08565 7 Best When Used By Dates 12MAY2026 18MAY2026
Recalling firm:
Mondelez Global Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0274-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Aleve 1's, 60 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0262-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

NYQUIL COLD & FLU -32CT/2PK

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0273-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

EXCEDRIN 2'S DISP.- 30 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0269-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Bayer 2Pk- 25 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0265-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

PEPCID COMPLETE - 25CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0276-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Claritin, 20 Count, UPC: 655708016305

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0266-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0279-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

PEPTO BISMOL 32CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0275-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

MOTRIN 2'S DISP.- 50CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0271-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0285-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0261-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0281-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0278-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

DAYQUIL COLD & FLU, 32CT/2PK

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0267-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0272-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 26, 2025

Benadryl, 25'S 2PK Box, UPC 815556020316

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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-0264-2026
Lot/product code:
All lots within expiry distributed by Gold Star Distribution.
Recalling firm:
GOLD STAR DISTRIBUTION INC
View official FDA record (opens in a new tab)