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Recalls affecting Delaware

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

16,320 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)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI# VSV (863067): 00884838009578
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI# VS4 (863283): 00884838087095
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI# VS3 (863069): 00884838000094, (863070): 00884838000100, (863071): 00884838000117, (863072): 00884838000124, (863073): 00884838000131, (863074): 00884838000148
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI#'s VM3 (863077): 00884838028791 VM4 (863063): 00884838000032, (863085): 00884838028807 VM6 (863064): 00884838000049, (863065): 00884838000056, (863086): 00884838028814 VM8 (863066): 00884838000063, (863068): 00884838000087, (863087): 00884838028821, (863088): 00884838028838, (863317): 00884838050464
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2018

Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility.

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

ALL 50 STATES
Full report

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

Recall #:
80645
Lot/product code:
UDI# VS2 (863079): 00884838009639, (863080): 00884838009646, (863081): 00884838009653, (863082): 00884838009660
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 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 43547-311-09

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-0972-2018
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 and Hydrochlorothiazide, USP, 320 MG/25 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 43547-315-09

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-0976-2018
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 and Hydrochlorothiazide, USP, 160 MG/25 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 43547-313-09

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-0974-2018
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 and Hydrochlorothiazide, USP, 320 MG/12.5 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 43547-314-09

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-0975-2018
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 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)
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)
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 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, 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)
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 14, 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.

The product may be counterfeit and could have microbial issues.

ALL 50 STATES
Full report

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

Recall #:
83595
Lot/product code:
Lot numbers 31248224, exp. 2021/06; 31251806, exp. 2021/07; 31252524, exp. 2021/07; 31202568, exp. 2020/09; 31247324, exp. 2021/06; 31255298, exp. 2021/08; 31231184, exp. 2021/03; 31257909, exp. 2021/08; 31247744, exp. 2021/06; 31240720, exp. 2021/04; 31252252, exp. 2021/07; 31251559, exp., 2021/07; 31243321, exp. 2021/05; 31259174, 2021/09; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31242179, exp. 2021/05; 31251806, exp. 2021/07; and 31252524, exp. 2021/07.
Recalling firm:
Lens.com
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 15, 2018

da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

ALL 50 STATES
Full report

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

Recall #:
80696
Lot/product code:
Model Number 47179-14 Device Listing D215864 UDI Number 00886874112298 Lot Numbers: S11160307 N11171009 N10171010 N10171012 N10180219 N10180214 N10180212 N10180220 N10180221 N10171017 N10180213 N10180215 T10180212 N11180212 T10180208 N10171002 N10170921 N10171023 N10171018 N10170819 N10170818 N10170911 N10170807 N10170808 N10170914 N10171016 N10170718 N10171019 N10171005 N10171009 N10171004 N10171003 N11170911 N10170927 N10170926 N10170815 N11170922 N11170912 N10170809 N10170814 N10170925 N10170922 N10170728 N10170713 N10170912 N10170614 N10170906 N10170824 N10170703 N10170816 N10170811 T10170720 N10170727 N10170724 N10170712 N10170803 N10170721 N10170802 N10170602 N10170720 N10170620 N10170719 N10170801 N10170714 N10170619 N10170711 S10170525 N10170626 N10170613 N11170513 N10170706 N11170223 N10170531 N10170628 N10170612 N10170629 S10170705 S10170523 N10170616 N10170605 N10170615 N10170307 N10170622 N10170518 N10170609 N10170607 N10170504 N10170606 N11161213 N10160831 N10170317 N10170418 N10170601 N10170526 N10170405 N10170511 N10170524 N10170522 N10170508 N10170519 N10170513 N10170515 N11170306 N10170509 N10170516 N10170428 N12170223 S10170501 S10170223 N11170429 N10170427 N11170428 N10170406 N10170429 N10170426 N10170420 N10170424 N10170419 N10170324 N10170328 N10170417 N11170224 S10170417 N10170411 N10170224 N10170412 N10170410 N10170303 N10170404 N11170120 N11170405 N10170403 S10170405 N10170331 N10170302 N10170314 N10170321 N10170131 N10170306 N11170327 N10170309 S10161213 N10170327 N10170117 N10170323 N10170301 N10170313 N10170316 N10170315 N11161117 S10170317 N10170310 N10170227 N10170216 N11161215 N12170306 N10170222 N11170216 S10161130 N11170301 N10170228 S10170224 N10170223 N10170127 N10170217 N10170214 N10170209 N10170207 N11170214 N11170117 N10170215 N11170104 N10170210 N10170208 S10170125 N10170110 N10170112 N10170203 N10170130 N10170123 N11170123 S10161207 N10170120 N11170112 S10170120 N10170125 S10161208 S10170201 N11170125 N10170104 S10170126 N10170119 N10161205 N10161216 N10161228 N11170110 N11161216 N10161117 N11161130 N11170105 N10161202 N10161026 N10170105 N10161004 N11161221 N10161011 N10161229 N11161212 N11161209 N10161221 N10161215 N11161014 N10161214 S10161117 N10161213 N10161212 N10161124 N10160921 N10161209 N10161130 S10160922 N11161122 N10160809 N10161107 N10161122 N11161114 N11161111 N11161107 S10161116 N10160912 N10161111 N10160908 N10161103 S10160901 N10161114 N10161018 N10161104 N10161110 N11161104 N10160802 N10161102 N10160727 S10161108 S10160428 N11161028 N10161006 N10161025 N10161028 N10161024 N10160919 S10161024 N10161021 N11160905 N10161014 N11161018 S10161020 N10160915 S10161019 S10161013 N10160822 S10160307 S10161012 N10160824 N11161006 N11160706 N10160719 N11160912 S10161003 N10160914 N11160816 N10160926 N10160816 N10160525 N11160926 S10160614 N10160920 S10160927 S10160527 N10160811 S10160916 N10160905 N10160825 N11160831 S10160811 N11160725 S10160728 S10160718 N10160823 N11160825 S10160712 S10160705 N11160427 N10160728 S10160817 N11160808 S10160815 N10160808 N10160801 N11160601 N10160725 N10160803 N10160527 S10160803 N10160607 N10160714 N10160720 S10160713 S10160506 S10160629 N10160713 N11160720 N11160714 N11160628 N10160708 N10160405 N10160706 N10160628 N10160701 S10160324 N10160624 N11160624 S10160321 N10160617 N10160526 N10160615 N10160620 N10160613 N10160610 N10160608 S10160415 N10160506 N10160606 N10160519 N10160601 N10160517 N10160524 S10160513 N10160520 N10160516 N10160418 N10160513 N10160512 N10160511 N10160505 N12160316 N10160504 N10160428 N10160427 N10160316 N11160316 S10160422 N10160426 N10160419 N10160331 N10160414 N10160412 N10160329 S10160406 S10160318 N10160404 S10160401 S10160302 S10160325 N10160301 S10160229 S10160227 S10160219 S12160114 S11160114 S10160114
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 15, 2018

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0081-2019
Lot/product code:
Lot #: MON17384, Exp 12/19
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 15, 2018

da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

ALL 50 STATES
Full report

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

Recall #:
80696
Lot/product code:
Model Number 420179-16 Device Listing D088920 UDI Number 00886874111505 Lot Numbers: N10170912 N10170928 N10170419 N10170927 N10170919 N10171009 N10170731 N10170529 N11170912 N11170909 N10170828 N10170922 N10161014 N10170522 N10170808 N10170904 N10171010 N10170920 N10170921 N10170804 N10170905 N11170905 N11170725 N10170918 N10170703 N10170911 N11170920 N10171004 N11170227 N10170908 N10170821 N10170801 N10170725 N10170822 N10170524 N10161019 N11160701 N10170705 N11170703 N11170705 N11170522 N11170605 N10170605 N10170516 N10170602 N11170419 N10170308 N11170308 N10170508 N10170303 N12170308 N10170418 N12170310 N10170412 N11170412 N12170412 N10170407 N10170502 N11170207 N10170321 N14170310 N11170202 N11170119 N11170303 N10161129 N13170310 N11170407 N11170214 N11170310 N10170310 N12170214 N10170213 N10170130 N10170202 N11161115 N10170207 N12170123 N10161018 N10170214 N11161014 N10161222 N11170213 N10170119 N11170123 N11161129 N11161212 N10170123 N10161208 N11160926 N11161021 N11170105 N12160707 N10170105 N10161212 N10161115 N11161025 N11161118 N10161118 N10161021 N11161122 N10161026 N10161122 N10161031 N10160701 N11161026 N10161025 N11160608 N10160708 N10160824 N11160629 N11161019 N10160926 N12160824 N11160913 N10160808 N11160808 N10160707 N10160913 N11160622 N13160824 N11160824 N10160608 N10160305 N10160524 N14160824 N11160705 N10160705 N10160714 N10160603 N11160511 N11160708 N10160217 N10160420 N10160429 N10160629 N11160425 N11150929 N10160511 N10160622 N11160429 N10160212 N10160322 N12150929 N10160614 N11160614 N11160603 N10160510 N11160309 N10160523 N11160129 N10160323 N10160328 N10150929 N10160202 N10160425 N10160413 N11160413 N10160406 N10160408 N10160316 N10160401 N10160309 N10160121 N10160129 N10160226 N10160229 N11160301 N10160227 N10160211 N11160202
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)