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Recalls affecting Maryland

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

16,826 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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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
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)
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

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: 00884450024140
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled April 2, 2026

Wawa Diet Lemonade Pint (16oz), Plastic bottle

Not listed on the label Milk Allergen,

Full report

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

Recall #:
H-0857-2026
Lot/product code:
UPC: 726191055901
Recalling firm:
Wawa Beverage Company
View official FDA record (opens in a new tab)
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)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled April 2, 2026

Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle

Not listed on the label Milk Allergen,

Full report

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

Recall #:
H-0856-2026
Lot/product code:
UPC: 726191018548
Recalling firm:
Wawa Beverage Company
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled April 2, 2026

Wawa Fruit Punch Pint (16oz), Plastic bottle

Not listed on the label Milk Allergen,

Full report

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

Recall #:
H-0858-2026
Lot/product code:
UPC: 726191018432
Recalling firm:
Wawa Beverage Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 2, 2026

Uric Acid in vitro diagnostic test REF: 31H0P

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: 08806141303077/ Lot: 241023, 250415, 250509, 250617, 250905
Recalling firm:
DFI Co., Ltd.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusE. coliRecalled April 2, 2026

RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156

Multi-state outbreak of E. coli O157:H7.

Full report

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

Recall #:
H-0762-2026
Lot/product code:
8 oz - BATCH: 20260212, BEST BY: 5/13/2026 and all prior batches/dates. 16 oz - BATCH: 20251027-4, BEST BY: 8/23/2026 and all prior batches/dates.
Recalling firm:
Raw Farm LLC
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 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)
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)
Class IIModerate risk
DrugRecalled April 2, 2026

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (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-0529-2026
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 1, 2026

i-STAT G3+ cartridge; List Number: 03P78-26;

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: 03P78-26; UDI-DI: 00054749005673; Lot number: N25221;
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)
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

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)
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

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)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2026

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

ALL 50 STATES
Full report

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

Recall #:
98754
Lot/product code:
UDI-DI: 03663537018763; Lot Number: FD1265
Recalling firm:
Aniara Diagnostica 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)
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 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

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, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

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-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)