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Recalls affecting West Virginia

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

16,444 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 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 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 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)
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 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

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 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 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 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/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 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 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

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

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

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 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 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)
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.

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▸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

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
82039
Lot/product code:
Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC70 w/trolley Government Bundle, Product 860352, 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:
US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
▸Full report

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

Recall #:
82039
Lot/product code:
Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969
Recalling firm:
ConvaTec, Inc
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)