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Recalls affecting Hawaii

Data last updated: September 9, 2026 at 1:18 PM UTC

16,268 recalls found
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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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

One Step P in vitro diagnostic test REF: 8194

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI:08806141302025/ Lot: 241023, 250527, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

ALL 50 STATES
▸Full report

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

Recall #:
98680
Lot/product code:
Siemens Material Number (SMN): 10736515; UDI-DI: 00809708121860; Lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only);
Recalling firm:
Siemens Healthcare Diagnostics Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 2, 2026

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

Not guaranteed to be germ-free; potential for leakage from the diaphragm port once the foil is removed.

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-0498-2026
Lot/product code:
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
Recalling firm:
B BRAUN MEDICAL INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 2, 2026

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

Not guaranteed to be germ-free; potential for leakage from the diaphragm port once the foil is removed.

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-0496-2026
Lot/product code:
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Recalling firm:
B BRAUN MEDICAL INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Catheter may experience resistance when being advanced over the guidewire

ALL 50 STATES
▸Full report

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

Recall #:
98637
Lot/product code:
All Lot Numbers/UDI: 00884450816509
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 2, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)

Not guaranteed to be germ-free

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-0532-2026
Lot/product code:
All lots within expiry
Recalling firm:
Huons Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

One Step pH in vitro diagnostic test REF: 31I4P

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI: 08806141303060/ Lot: 250305, 250415, 250509, 250625, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

One Step 10A in vitro diagnostic test

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI:08806141302650/ Lot: 241023, 250625, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 2, 2026

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Not guaranteed to be germ-free; potential for leakage from the diaphragm port once the foil is removed.

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-0497-2026
Lot/product code:
Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
Recalling firm:
B BRAUN MEDICAL INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

ALL 50 STATES
▸Full report

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

Recall #:
98682
Lot/product code:
G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots 16886459 16874181 16855513 16867505 16815763 16796665 16802282 16766437 16734169 16695772 G31216 UDI-DI 00827002312166 Lots 16886460 16891299 16912494 16831676 16836358 16836359 16836360 16864534 16864652 16881655 16882508 16912493 16872559 16878260 16824312 16831675 16874182 16855514 16868889 16859732 16858079 16878261 16806270 16804619 16805454 16804399 16815762 16803920 16803921 16802096 16802097 16814369 16814370 16806333 16804620 16831528 16822289 16822290 16782945 16782946 16795733 16796300 16779437 16795734 16800424 16802632 16824313 16764526 16763024 16800730 16802633 16802133 16800731 16821105 16824314 16711110 16717839 16730326 16720153 16736740 16739291 16693653 16690051 16673569 16680240 16704378 G31220 UDI-DI 00827002312203 Lots 16881657 16872241 16827163 16852999 16805455 16804400 16802132 16779438 16730325 16739292 16700199 16690050 16661312 16674400 G31221 UDI-DI 00827002312210 Lots 16839296 16879977 16814371 16821104
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

One Step UTI in vitro diagnostic test REF: 3374

The devices were distributed without required FDA premarket clearance or approval.

ALL 50 STATES
▸Full report

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

Recall #:
98739
Lot/product code:
UDI: 08806141303480/ Lot: 241023, 250625, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

ALL 50 STATES
▸Full report

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

Recall #:
98741
Lot/product code:
Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
Recalling firm:
Windstone Medical Packaging, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

CGMP deviations.

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-0507-2026
Lot/product code:
120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1

Not guaranteed to be germ-free

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-0483-2026
Lot/product code:
Lot Number: EA038A5, Expiration Date: 08/2026.
Recalling firm:
International Medication Systems Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2026

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Respiratory/sore throat panel test may result in false negative results and control failures.

ALL 50 STATES
▸Full report

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

Recall #:
98719
Lot/product code:
Lot Number: 2215125/UDI: 00815381020390
Recalling firm:
BioFire Diagnostics, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Failed Stability Specifications

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-0487-2026
Lot/product code:
Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027
Recalling firm:
Island Kinetics, Inc. d.b.a. CoValence Laboratories
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2026

i-STAT EG7+ cartridge; List Number: 03P76-25;

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

ALL 50 STATES
▸Full report

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

Recall #:
98635
Lot/product code:
List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;
Recalling firm:
Abbott Point Of Care Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

CGMP deviations.

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-0504-2026
Lot/product code:
120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

CGMP deviations.

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-0508-2026
Lot/product code:
Lot 020226202150202, Exp Date 05/05/2026.
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

CGMP deviations.

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-0505-2026
Lot/product code:
Lot 011226204250063, Exp Date 05/14/2026
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2026

i-STAT EG6+ cartridge; List Number: 03P77-25;

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

ALL 50 STATES
▸Full report

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

Recall #:
98635
Lot/product code:
List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;
Recalling firm:
Abbott Point Of Care Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

CGMP deviations.

ALL 50 STATES
▸Full report

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

Recall #:
D-0502-2026
Lot/product code:
120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date 05/29/2026, 012826122030181, Exp Date 05/30/2026, 012826122030182, Exp Date 05/30/2026, 020226122030201, Exp Date 06/04/2026, 020326122030217, Exp Date 06/05/2026, 020426122030235, Exp Date 06/06/2026, 020426122030242, Exp Date 06/06/2026, 020426122030241, Exp Date 06/06/2026, 020626122030260, Exp Date 06/09/2026, 020626122030256, Exp Date 06/09/2026, 020926122030303, Exp Date 06/11/2026, 021026122030308, Exp Date, 06/12/2026, 021126122030321, Exp Date 06/13/2026, 021126122030316, Exp Date 06/13/2026, 021226122030326, Exp Date 06/16/2026, 021326122030341, Exp Date 06/17/2026, 021726122030366, Exp Date 06/19/2026, 021726122030369, Exp Date 06/19/2026, 021826122030388, Exp Date 06/20/2026, 022026122030421, Exp Date 06/24/2026, 022026122030420, Exp Date 06/24/2026, 022326122030435, Exp Date, 06/25/2026, 031026122030552, Exp Date 07/10/2026, 031026122030553, Exp Date 07/10/2026
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 1, 2026

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

CGMP deviations.

ALL 50 STATES
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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0506-2026
Lot/product code:
Lot 022326203650432; Exp Date 06/25/2026
Recalling firm:
Wells Pharma of Houston LLC
View official FDA record (opens in a new tab)