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Recalls affecting Tennessee

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

17,051 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 August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1141-2018
Lot/product code:
Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1135-2018
Lot/product code:
Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1138-2018
Lot/product code:
Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1144-2018
Lot/product code:
Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1137-2018
Lot/product code:
Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1136-2018
Lot/product code:
Batch: BV48D001, BV48D002
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1145-2018
Lot/product code:
Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1139-2018
Lot/product code:
Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1142-2018
Lot/product code:
Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1143-2018
Lot/product code:
Batch: BBY2E001, BBY2D001, BBY2D002
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 15, 2018

HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BRANDS, INC. SAVANNAH, GA 31405

During a label check the firm noticed that the product was shipped with the incorrect label. The label is missing the following ingredients: Soybean Oil, Onion Powder & EDTA.

CAGAILLAMAMINCNJOHPATN
▸Full report

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

Recall #:
F-0667-2019
Lot/product code:
Product still within shelf life (Lot Codes: MH1371J, MH1511J, MK1631J, MH1781J, MI1841J, MI2121J, MH2261J, MI2431J, MH2671J) Product out of shelf life (Lot Codes: MI0111J, MI0301J, MI0441J, MI0491J, MH0571J, MH0661J, MH0831J, MK1021J)
Recalling firm:
Diamond Crystal Brands, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0317-2019
Lot/product code:
Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0314-2019
Lot/product code:
Lot # 3071352, exp. date 7/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0316-2019
Lot/product code:
Lot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0315-2019
Lot/product code:
Lot # 3061169, exp. date 11/2018
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0318-2019
Lot/product code:
Lot # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0311-2019
Lot/product code:
Lot # 3066051, exp. date 3/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0313-2019
Lot/product code:
Lot # 3063782, exp. date 1/2019
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 20, 2018

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained 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-0312-2019
Lot/product code:
Lot # 3079500, exp. date 1/2020
Recalling firm:
Mylan Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0303-2019
Lot/product code:
NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0309-2019
Lot/product code:
NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0308-2019
Lot/product code:
NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0306-2019
Lot/product code:
NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0304-2019
Lot/product code:
NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 27, 2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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-0310-2019
Lot/product code:
All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)