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Recalls affecting Utah

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

16,598 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 20, 2018

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0504-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0501-2019
Lot/product code:
Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 20, 2018

LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0505-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0502-2019
Lot/product code:
Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 20, 2018

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0503-2019
Lot/product code:
Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

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-1039-2019
Lot/product code:
Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

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-1037-2019
Lot/product code:
Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0368-2019
Lot/product code:
Lot # HVSA17011-A, exp. date 11/2020 Lot # HVSA17012-A, exp. date 11/2020 Lot # HVSA18001-A, exp. date 12/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

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-1036-2019
Lot/product code:
Lot Numbers: VFSA17007-A, exp. date Oct-2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0361-2019
Lot/product code:
Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0364-2019
Lot/product code:
Lot # VKSA18005-A, exp. date 03/2020 Lot # VKSA18001-A, exp. date 01/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0369-2019
Lot/product code:
Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0370-2019
Lot/product code:
Lot # VUSD17008-A, exp. date 07/2019 Lot # VUSD17009-A, exp. date 09/2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0362-2019
Lot/product code:
Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0365-2019
Lot/product code:
Lot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0363-2019
Lot/product code:
Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

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-1038-2019
Lot/product code:
Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0366-2019
Lot/product code:
Lot # HTSA17033-A, exp. date 10/2020 Lot # HTSA17034-A, exp. date 10/2020 Lot # HTSA17035-A, exp. date 10/2020 Lot # HTSA17036-A, exp. date 10/2020 Lot # HTSA17040-A, exp. date 10/2020 Lot # HTSA17041-A, exp. date 11/2020 Lot # HTSA17042-A, exp. date 11/2020 Lot # HTSA17043-A, exp. date 11/2020 Lot # HTSA17037-A, exp. date 10/2020 Lot # HTSA17039-A, exp. date 10/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0367-2019
Lot/product code:
Lot # HTSB17049-A, exp. date 08/2020 Lot # HTSB17054-A, exp. date 10/2020 Lot # HTSB17055-A, exp. date 10/2020 Lot # HTSB17056-A, exp. date 10/2020 Lot # HTSB17057-A, exp. date 10/2020 Lot # HTSB17058-A, exp. date 10/2020 Lot # HTSB17059-A, exp. date 10/2020 Lot # HTSB17060-A, exp. date 10/2020 Lot # HTSB17062-A, exp. date 10/2020 Lot # HTSB17066-A, exp. date 10/2020 Lot # HTSB17067-A, exp. date 11/2020 Lot # HTSB17068-A, exp. date 11/2020 Lot # HTSB17069-A, exp. date 11/2020 Lot # HTSB18001-A, exp. date 12/2020 Lot # HTSB18002-A, exp. date 12/2020 Lot # HTSB18003-A, exp. date 12/2020 Lot # HTSB18004-A, exp. date 12/2020 Lot # HTSB18005-A, exp. date 12/2020 Lot # HTSB18006-A, exp. date 12/2020 Lot # HTSB18007-A, exp. date 12/2020 Lot # HTSB17063-A, exp. date 10/2020 Lot # HTSB17064-A, exp. date 10/2020 Lot # HTSB17065-A, exp. date 10/2020 Lot # HTSB18029-A, exp. date 03/2021
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

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-1035-2019
Lot/product code:
Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2019

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85642
Lot/product code:
Product Product Description Lot Number Number 14-32211507 A Link Z Ti Unitary Plate-Cage 32x21x15 7 1000638 14-32211512 A Link Z Ti Unitary Plate-Cage 32x21x15 12 1000259 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000260 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000325 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000529 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000261 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000469 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000556 14-32211712 A Link Z Ti Unitary Plate-Cage 32x21x17 12 1000262 14-32211716 A Link Z Ti Unitary Plate-Cage 32x21x17 16 1000640 14-32211720 A Link Z Ti Unitary Plate-Cage 32x21x17 20 1000641 14-32211920 A Link Z Ti Unitary Plate-Cage 32x21x19 20 1000530 14-32241507 A Link Z Ti Unitary Plate-Cage 32x24x15 7 1000211 14-32241516 A Link Z Ti Unitary Plate-Cage 32x24x15 16 1000536 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000282 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000583 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000232 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000383 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000479 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000652 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000233 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000360 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000584 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577
Recalling firm:
Acuity Surgical Devices, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2019

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85642
Lot/product code:
Product Product Description Lot Number Number 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577
Recalling firm:
Acuity Surgical Devices, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81957
Lot/product code:
CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096 CN11510097 CN11510098 CN11630118 CN11630119 CN11630120 CN11630121 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630127 CN11630128 CN11630129 CN11630130 CN11630131 CN11630137 CN11630139 CN11630140 CN11630141 CN11630142 CN11630149 CN11630150 CN11630151 CN11630152 CN11630153 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630161 CN11630162 CN11630163 CN11630164 CN11630165 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11731415 CN11731422 CN11731423 CN11731424 CN11731425 CN11731426 CN11731427 CN11731428 CN11731429 CN11731430 CN11731431 CN11731432 CN11731433 CN11731434 CN11731435 CN11731436 CN11731437 CN11731438 CN11731439 CN11731440 CN11731441 CN11731442 CN11731443 CN11731444 CN11731445 CN11731446 CN11731447 CN11731448 CN11731449 CN11731450 CN11731452 CN11731453 CN11731454 CN11731455 CN11731456 CN11731457 CN11731463 CN11731464 CN11731465 CN11731466 CN11731467 CN11731468 CN11731469 CN11832357 CN11832358 CN11832359 CN11832360 CN11832361 CN11832362 CN11832363 CN11832368 CN11832369 CN11832370 CN11832371 CN11832372 CN11832373 CN11832378 CN11832379 CN11832380 CN11832381 CN11832382 CN11832383 CN11832384 CN11832385 CN11832386 CN11832387 CN11832388 CN11832389 CN11832390 CN11832391 CN11832392 CN11832393 CN11832394 CN11832395 CN11832396 CN11832397 CN11832398 CN11832399 CN11832405 CN11832406 CN11832407 CN11832408 CN11832409 CN11832410 CN11832411 CN11832412 CN11832413 CN11832414 CN11832415 CN11832416 CN11832417 CN11832418 CN11832419 CN11832420 CN11832421 CN11832422 CN11832423 CN11832424 CN11832425 CN11832426 CN11832427 CN11832428 CN11832429 CN11832430 CN11832431 CN11832432 CN11832434 CN11832435 CN11832436 CN11832437 CN11832438 CN11832439 CN11832440 CN11832441 CN11832442 CN11832443 CN11832444 CN11832445 CN11832446 CN11832447 CN11832448 CN11832449 CN11832450 CN11832451 CN11832452 CN11832453 CN11832454 CN21102482 CN21102483 CN21102484 CN21102485 CN21102486 CN21102487 CN21204898 CN21204899 CN21204902 CN21204903 CN21204904 CN21204905 CN21204913 CN21204914 CN21204915 CN21204916 CN21204917 CN21204918 CN21204919 CN21204920 CN21204921 CN21204922 CN21204923 CN21204924 CN21204925 CN21204926 CN21204927 CN21204928 CN21204929 CN21204930 CN21204931 CN21204932 CN21204933 CN21204934 CN21204935 CN21204936 CN21204937 CN21204938 CN21204939 CN21204940 CN21204941 CN21204942 CN21204943 CN21204944 CN21204945 CN21204946 CN21204947 CN21205039 CN21205068 CN21205069 CN21205070 CN21205071 CN21205072 CN21205073 CN21205074 CN21205075 CN21205076 CN21205077 CN21205078 CN21205079 CN21205080 CN21205081 CN21205082 CN21205083 CN21205093 CN21205094 CN21306944 CN21306947 CN21306948 CN21306949 CN21306950 CN21306951 CN21408619 CN21408620 CN21510155 CN21510156 CN21510157 CN21510158 CN21510159 CN21510160 CN21510161 CN21510162 CN21510163 CN21510164 CN21510165 CN21510166 CN21510167 CN21510168 CN21510169 CN21510170 CN21510171 CN21510172 CN21510173 CN21510174 CN21510206 CN21510207 CN21510208 CN21510209 CN21510210 CN21510211 CN21510212 CN21510213 CN21510214 CN21510215 CN21510216 CN21510217 CN21510218 CN21510221 CN21510232 CN21510233 CN21510234 CN21510235 CN21510236 CN21510237 CN21510238 CN21510239 CN21510240 CN21510241 CN21510242 CN21510243 CN21510244 CN21510245 CN21510246 CN21510247 CN21510248 CN21510249 CN21510327 CN21510328 CN21510329 CN21510330 CN21510331 CN21510332 CN21510333 CN21510334 CN21510335 CN21510336 CN21510337 CN21510338 CN21510341 CN21510342 CN21510343 CN21510344 CN21510345 CN21510346 CN21510347 CN21510348 CN21510349 CN21510350 CN21510351 CN21510352 CN21510353 CN21510354 CN21510355 CN21510356 CN21510357 CN21510358 CN21510359 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630269 CN21630272 CN21630273 CN21630274 CN21630275 CN2163… (truncated, 145628 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81957
Lot/product code:
CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779 US10901782 US10901783 US10901784 US10901785 US10901786 US10901787 US10901788 US10901789 US10901790 US10901791 US10901792 US10901793 US10901794 US10901795 US10901796 US10901797 US10901798 US10901799 US10901800 US10901801 US10901802 US10901803 US10901804 US10901805 US10901806 US10901807 US10901808 US10901809 US10901810 US10901811 US10901812 US10901813 US10901814 US10901815 US10901816 US10901817 US10901818 US10901819 US10901821 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873 US10901874 US10901887 US10901888 US10901889 US10901890 US10901891 US10901892 US10901893 US10901894 US10901895 US10901896 US10901897 US10901898 US10901899 US10901900 US10901901 US10901902 US10901907 US10901908 US10901909 US10901910 US10901911 US10901912 US10901913 US10901914 US10901915 US10901916 US10901917 US10901918 US10901919 US10901920 US10901921 US10901922 US10901923 US10901924 US10901925 US10901926 US10901927 US10901928 US10901929 US10901930 US10901931 US10901932 US10901933 US10901934 US10901938 US10901939 US10901940 US10901941 US10901942 US10901943 US10901944 US10901945 US10901946 US10901947 US10901948 US10901949 US10901950 US10901951 US10901952 US10901953 US10901954 US10901955 US10901956 US10901957 US10901958 US10901959 US10901960 US10901961 US10901962 US10901963 US10901964 US10901965 US10901966 US10901967 US10901968 US10901969 US10901970 US10901971 US10901972 US10901973 US10901974 US10901975 US10901976 US10901977 US10901978 US10901979 US10901980 US10901981 US10901982 US10901983 US10901984 US10901985 US10901986 US10901987 US10901988 US10901989 US10901990 US10901991 US10901992 US10901993 US10901994 US10901995 US10901996 US10901997 US10901998 US10901999 US10902000 US10902001 US10902002 US10902003 US10902004 US10902005 US10902006 US10902007 US10902008 US10902009 US10902010 US11003987 US11003988 US11003989 US11003990 US11003991 US11003992 US11003993 US11003994 US11003995 US11003996 US11003997 US11003998 US11003999 US11004000 US11004001 US11004002 US11004003 US11004004 US11004005 US11004006 US11004007 US11004008 US11004009 US11004010 US11004011 US11004012 US11004013 US11004014 US11004015 US11004016 US11004017 US11004018 US11004019 US11004020 US11004021 US11004022 US11004024 US11004025 US11004026 US11004027 US11004028 US11004029 US11004030 US11004031 US11004032 US11004033 US11004034 US11004035 US11004036 US11004037 US11004038 US11004039 US11004040 US11004041 US11004042 US11004043 US11004044 US11004045 US11004046 US11004047 US11004048 US11004049 US11004050 US11004051 US11004052 US11004053 US11004054 US11004055 US11004056 US11004057 US11004058 US11004059 US11004060 US11004061 US11004062 US11004063 US11004064 US11004065 US11004066 US11004068 US11004069 US11004070 US11004071 US11004072 US11004073 US11004074 US11004075 US11004076 US11004077 US11004078 US11004079 US11004080 US11004081 US11004082 US11004083 US11004084 US11004085 US11004086 US11004087 US11004088 US11004089 US11004090 US11004091 US11004092 US11004093 US11004094 US11004095 US11004096 US11004097 US11004098 US11004099 US11004100 US11004101 US11004102 US11004103 US11004104 US11004105 US11004106 US11004107 US11004108 US11004109 US11004110 US11004111 US11004112 US11004113 US11004114 US11004115 US11004116 US11004117 US11004118 US11004119 US11004120 US11004121 US11004122 US11004123 US11004124 US11004125 US11004126 US11004127 US11004128 US11004129 US11004130 US11004131 US11004132 US11004133 US11004134 US11004135 US11004136 US11004137 US11004138 US11004139 US11004140 US11004141 US11004142 US11004143 US11004144 US11004145 US11004146 US11004147 US11004148 US11004149 US11004150 US11004151 US11004152 US11004153 US11004154 US11004155 US11004156 US11004157 US11004158 US11004159 US11004161 US11004162 US11004163 US11004164 US11004165 US11004166 US11004167 US11004168 US11004169 US11004170 US11004171 US11004172 US11105738 US11105739 US11105740 US11105741 US11105742 US11105743 US11105744 US11105745 US11105746 US11105747 US11105748 US11105749 US11105750 US11105751 US11105752 US11105753 US11105754 US11105755 US11105756 US11105757 US11105758 US11105759 US11105760 US11105761 US11105762 US11105763 US11105764 US11105765 US11105766 US11105767 US11105768 US11105769 US11105770 US11105771 US11105772 US11105773 US11105774 US11105775 US11105776 US11105777 US11105778 US11105779 US11105780 US11105781 US1110… (truncated, 166197 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81957
Lot/product code:
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… (truncated, 154736 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)