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Recalls affecting Nebraska

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

16,502 recalls found
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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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
Class IIModerate risk
DrugRecalled August 18, 2023

Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01

Weaker than it should be Drug: Product does not contain SPF that is declared on the label.

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-1175-2023
Lot/product code:
Lot #: 1732A, 1732B, 1742A, 1742B, 1742C, 1742D; Exp. 06/2024.
Recalling firm:
HUMANRACE
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusListeriaRecalled August 18, 2023

Mixed Vegetables BEST PRICE TOPVALU, net per bag 500g. Label is in foreign language. 4549414484120 Food Lion Mixed Vegetables Carrots, Corn, Green Beans & Peas. Product of USA, net wt. per bag 16oz, 12 bags per case. Distributed by Food Lion, LLC Salisbury, NC. UPC 35826005090 Kroger Mixed Vegetables Carrots, Super Sweet Corn, Green Beans & Green Peas. Product of USA, net wt. per bag 12oz, 14 bags per case. Distributed by The Kroger C. Cincinnati, OH. UPC 11110849625 Kroger Mixed Vegetables Carrots, Super Sweet Corn, Green Beans & Green Peas. Product of USA, net wt. per bag 32oz, 6 bags per case. Distributed by The Kroger C. Cincinnati, OH. UPC 11110865854

Listeria monocytogenes

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 #:
F-1506-2023
Lot/product code:
BEST PRICE TOPVALU: 2025.01.06 Food Lion: 50183 BEST BY 18 JAN 2025 Kroger 12oz: 53122 BEST IF USED BY MAY 2024 53412 BEST IF USED BY JUN 2024 BEST IF USED BY APR.2024 82942 BEST IF USED BY APR.2024 83012 BEST IF USED BY AUG.2024 80463 Kroger 32oz. BEST IF USED BY FEB.2024 82352
Recalling firm:
Twin City Foods, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusListeriaRecalled August 18, 2023

Individually Quick Frozen (IQF) Corn, distributed in bulk cases (1kg, 10kg, 12kg, 15kg, 25kg) to consignees for further processing. Cases are read in parts: Product of U.S.A. Packed By Twin City Foods, Inc. Stanwood, Washington. Super Sweet Grade A Cut Corn Blanched Vegetables, net wt. 12kg (12/1kg bags per case). Super Sweet Grade A Cut Corn Blanched Vegetable, net wt. 10kg Super Sweet Cut Corn Blanched Vegetables, net wt. 12kg Super Sweet Cut Corn Blanched Vegetables, LARGE, net wt. 12kg Super Sweet Grade A Cut Corn Blanched Vegetables, net wt. 15kg Super Sweet Grade A Triple Clean Cut Corn Blanched Vegetables, net wt. 15kg Super Sweet Grade A Cut Corn Blanched Vegetables, net wt. 25kg Super Sweet Grade A Triple Clean Cut Corn, net wt. 25kg

Listeria monocytogenes

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 #:
F-1504-2023
Lot/product code:
BULK CASES have the following codes and USE BY DATES: Super Sweet Grade A Cut Corn Blanched Vegetables, net wt. 12kg (12/1kg bags per case) has the USE BY dates: 2024.12.21 81723 2024.12.23 81743 2025.01.03 81843 Super Sweet Corn, net wt. 10kg, has the USE BY dates: 2025.06.22 31733 553293 330695 2025.06.23 31743 553293 330697 Super Sweet Cut Corn Blanched Vegetables, net wt. 12kg, has the USE BY dates: 2024.12.28 33622 553062 330246 2025.05.26 31463 553062 330621 2025.05.31 31513 553062 330633 Super Sweet Cut Corn Blanched Vegetables, LARGE, net wt. 12kg, has the USE BY dates: 2024.12.06 33402 553172 330193 2024.12.07 33412 553172 330197 2024.12.15 33492 553172 330227 2025.01.06 30063 553172 330266 2025.01.10 30103 553172 330275 2025.01.09 30093 553172 330270 2025.01.11 30113 553172 330279 2025.01.19 30193 553172 330311 2025.01.20 30203 553172 330313 2025.01.24 30243 553172 330329 2025.01.27 30273 553172 330342 2025.01.30 30303 553172 330347 2025.02.01 30323 553172 330355 2025.06.27 31783 553173 330703 Super Sweet Corn, net wt. 15kg, has the USE BY dates: 2025.05.15 31353 553032 330599 Super Sweet Corn Triple Clean, net wt. 15kg, has the USE BY dates: USE BY 2025.03.01 30603 555472 330407 USE BY 2025.06.19 31703 555473 330681 Super Sweet Cut Corn, net wt. 25kg, has the USE BY dates: USE BY 2025.05.10 31303 551932 330588 USE BY 2025.05.12 31323 551932 330595 Super Sweet Grade A Triple Clean Cut Corn, net wt. 25kg, has the USE BY dates: 2025.02.09 30403 553012 330377 2025.03.01 30603 553012 330409 2025.03.03 30623 553012 330415 2025.04.19 31093 553012 330534 2025.05.11 31313 553012 330592 2025.05.12 31323 553012 330596 2025.05.17 31373 553012 330605 2025.05.30 31503 553012 330630
Recalling firm:
Twin City Foods, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 25, 2023

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

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-1168-2023
Lot/product code:
Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2023

Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.

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-0036-2024
Lot/product code:
Lot: 6485, Exp: 11/23: 6562, Exp: 03/24; 6624, Exp: 06/24; 6669, Exp: 08/24; 6688, Exp: 09/24; 6727, EXP: 11/24; 6771, Exp: 02/25; 6830, Exp: 03/25; 6887, Exp: 07/25.
Recalling firm:
Dr. Berne's Whole Health Products
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2023

Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.

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-0034-2024
Lot/product code:
Lot: 6617, Exp. 05/24; 6623, Exp 06/24; 6646, Exp 07/24; 6675, Exp 09/24; 6716, Exp 11/24.
Recalling firm:
Dr. Berne's Whole Health Products
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2023

Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036

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-0033-2024
Lot/product code:
Lots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.
Recalling firm:
Dr. Berne's Whole Health Products
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2023

Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.

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-0035-2024
Lot/product code:
Lot: 6666, Exp. 11/30/25
Recalling firm:
Dr. Berne's Whole Health Products
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled September 19, 2023

Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slices in flexible film per pack, net wt. per pack 16oz, keep refrigerated. Single pack is sold at retail. Case UPC 0 00 2100007180 7; Single Pack UPC 0 2100061526 1: Each case contains 27 packs. Case UPC 0 00 2100061450 9; Single Pack UPC 0 2100061526 1: Each case contains 36 packs. Case UPC 0 00 2100061524 7; Carton UPC 0 2100060491 3; Single Pack UPC 0 2100061526 1; Each case contains 12 cartons, each carton contains 3 packs (72 slices total per carton).

Plastic fragment. Product is recalled due to potential for a thin strip of the primary packaging film to remain adhered to the cheese slice after the wrapper has been removed.

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 #:
F-0296-2024
Lot/product code:
Best When Used By Dates on 16oz Single Pack with the UPC of 0 2100061526 1 are: 10 JAN 24 S 72 through 27 JAN 24 S 72 Best When Used By Dates on 16oz Single Pack from the 3lb multipack carton with the UPC of 0 2100060491 3 are: 09 JAN 2024 through 13 JAN 2024, and 16 JAN 2024. Manufacturer Code on Case (UPC 0 00 2100061450 9): DD JAN 24 S 72/73 TT:TT. DD would be between 10-27. Manufacturer Code on Case (UPC 0 00 2100007180 7): XB ZZZ 23 021 DD JAN 2024. ZZZ would be between 163-165, 167, 169-173. Manufacturer Code on Case (UPC 0 00 2100061524 7): XB DDD 23 021 DD JAN 2024. DDD would be between 164-168, 171. DD would be between 09-13, and 16.
Recalling firm:
HEINZ
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 28, 2023

Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.

Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.

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-0041-2024
Lot/product code:
Lot #: 3TC22010, Exp 11/30/2024
Recalling firm:
Eugia US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 28, 2023

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

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-0081-2024
Lot/product code:
Lot#: 164185, Exp. Date 4/2024
Recalling firm:
Padagis US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 5, 2023

Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

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-0045-2024
Lot/product code:
Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.
Recalling firm:
Dollar Tree Distribution, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0097-2024
Lot/product code:
M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0098-2024
Lot/product code:
M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0096-2024
Lot/product code:
M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 20, 2023

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

Failed Dissolution Specifications

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-0095-2024
Lot/product code:
Lot #: 17220063, Exp 12/2023; 17220396, 17220397, Exp 01/2024; 17220965, Exp 04/2024; 17221187, 17221523, Exp 07/2024; 17221793, 17221794, 17221801, Exp 08/2024
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 23, 2023

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

Failed Dissolution Specifications: 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-0092-2024
Lot/product code:
Lot # 17230388, Exp. 01/31/2025
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 1, 2023

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Failed Impurities/Degradation Specifications-not meeting quality requirements (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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-0121-2024
Lot/product code:
Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 1, 2023

Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30

Failed Tablets/Capsules specifications; missing/broken/extra tablets within 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-0139-2024
Lot/product code:
Lot: 231104, 231105, 231106, exp 7/31/2025
Recalling firm:
Padagis US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 1, 2023

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Failed Impurities/Degradation Specifications-not meeting quality requirements (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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-0119-2024
Lot/product code:
Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 1, 2023

Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Failed Impurities/Degradation Specifications-not meeting quality requirements (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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

Recall #:
D-0122-2024
Lot/product code:
Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
Recalling firm:
Apotex Corp.
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Class IIModerate risk
DrugRecalled November 1, 2023

Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Failed Impurities/Degradation Specifications-not meeting quality requirements (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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

Recall #:
D-0120-2024
Lot/product code:
Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
Recalling firm:
Apotex Corp.
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Class IIModerate risk
DrugRecalled November 7, 2023

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

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

Recall #:
D-0123-2024
Lot/product code:
Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
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Class IIModerate risk
DrugRecalled November 7, 2023

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

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

Recall #:
D-0124-2024
Lot/product code:
Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
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Class IIModerate risk
DrugRecalled November 13, 2023

KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.

Failed Impurities/Degradation Specifications

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

Recall #:
D-0142-2024
Lot/product code:
Lot: CJ70900, CJ76796, Exp: 8/2024; CJ77051, Exp: 09/2024; WK02998, WK02997, WK04390, WK02999, Exp: 10/2024; WK03716, Exp:12/2024; WK05150, WK05151, WK07174, Exp:02/2025; WK05539, WK06534, Exp: 03/2025; WK10259, WK23040, Exp: 04/2025; WK27455, Exp: 08/2025.
Recalling firm:
KINDER FARMS LLC
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