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Recalls affecting Michigan

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

17,010 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 Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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

LipofitLipofit 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

KofinasGarlic 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 TemptationsChocolatey 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 SproutsRobust 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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled July 13, 2018

Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09

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-0969-2018
Lot/product code:
All lots within expiry.
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2018

Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09

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-0970-2018
Lot/product code:
All lots within expiry.
Recalling firm:
Prinston Pharmaceutical Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 17, 2018

Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0

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-1110-2018
Lot/product code:
Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195
Recalling firm:
A-S Medication Solutions LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 17, 2018

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

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-1108-2018
Lot/product code:
Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249
Recalling firm:
A-S Medication Solutions LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 17, 2018

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

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-1111-2018
Lot/product code:
Expiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239
Recalling firm:
A-S Medication Solutions LLC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 17, 2018

Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

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-1109-2018
Lot/product code:
Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170
Recalling firm:
A-S Medication Solutions LLC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 18, 2018

Sedecal NOVA FA DR System. for diagnostic radiography.

A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

ALL 50 STATES
Full report

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

Recall #:
81377
Lot/product code:
Serial Numbers 07360816 through 17291024
Recalling firm:
Sedecal S.A.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
(1) Trilliant Surgical Tiger Large Cannulated Screw System -  IFUs previous to Document #900-01-010 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-009 Rev. F; and  (2) Trilliant Surgical Large Cannulated Headless Screw System - IFUs previous to Document 900-01-014 Rev G and Cleaning and Sterilization Protocols previous to Document #900-06-012 Rev. D.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-002 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-009 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-008 Rev. H.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-012 Rev. F and Cleaning and Sterilization Protocols previous to Document #900-06-011 Rev. E.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-011 Rev. K and Cleaning and Sterilization Protocols previous to Document #900-06-010 Rev. G.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-005 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-006 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-014 Rev. C.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-008 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-016 Rev. C.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 19, 2018

Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

Full report

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

Recall #:
84977
Lot/product code:
IFUs previous to Document #900-01-004 Rev. P and Cleaning and Sterilization Protocols previous to Document #900-06-007 Rev. F.
Recalling firm:
Trilliant Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2018

Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

ALL 50 STATES
Full report

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

Recall #:
80804
Lot/product code:
Batteries with date code 3114 or older (Week 31 of 2014)
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 1, 2018

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.

ALL 50 STATES
Full report

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

Recall #:
84839
Lot/product code:
Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.
Recalling firm:
Allied Vision Group Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 8, 2018

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307

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-1113-2018
Lot/product code:
All Lots with expiration dates 7/2018 to 6/2020
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 8, 2018

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902

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-1116-2018
Lot/product code:
All Lots with expiration dates 7/2018 to 6/2020
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 8, 2018

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Full report

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

Recall #:
83088
Lot/product code:
Kit lots 1-17-5650, exp. 8/31/2018, and 2-17-5650, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.
Recalling firm:
Helena Laboratories, Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 8, 2018

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908

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-1114-2018
Lot/product code:
All Lots with expiration dates 7/2018 to 6/2020
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 8, 2018

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905

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-1115-2018
Lot/product code:
All Lots with expiration dates 7/2018 to 6/2020
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 8, 2018

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

Full report

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

Recall #:
83088
Lot/product code:
Kit lots 2-17-5651, exp. 8/31/2018, and 3-17-5651, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.
Recalling firm:
Helena Laboratories, Corp.
View official FDA record (opens in a new tab)