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Recalls affecting U.S. Virgin Islands

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

15,933 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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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)
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UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYNJ42828B UDI-DI 10198459425516 Lots 25GBQ173 25HBB240 25JBD028 25LBL133 26ABU673 26CBN583 26EBD855 26FBO892; DYNJ42832B UDI-DI 10198459425530 Lots 25LBE548 26BBG040 26CBH272 26EBC041 26FBD497
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
CDS860014Q UDI-DI 10198459629822 Lots 26ABR359 26BBP789 26CBL940 26DBK987 26FBK255 26FBK816 DYKM1000B UDI-DI 10889942508143 Lots 24KMD782 24LMH404 25AMD765 25BMD744 CDS860014P UDI-DI 10888277797819 Lots 24IBA155 24JBY045 24LBM014 25HBR509 25JBX951 DYNDV2684 UDI-DI 10198459185465 Lot 24LBP243
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYKS1583A UDI-DI 10198459146640 Lot 24KBP388
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYNDV1875 UDI-DI 10888277860209 Lot 24JMB689 ACC010972 UDI-DI 10198459303289 Lots 25DDA151 25DDA401 25EDA655 ACC010479A UDI-DI 10195327131517 Lot 25BDB620 ACC010690 UDI-DI 10195327433307 Lots 24LDB023 25BDA230 25GDA245 25JDB903 25KDB182 25LDA088 25LDA809 26ADC073 26CDA991 26DDB182 26EDA950 26EDB485 26FDB456 ACC010875 UDI-DI 10198459113659 Lots 24JDA648 25CDB776 25JDB205 25KDB028 25LDB271 26DDA182 26DDA786 26EDA629 ACC011073 UDI-DI 10198459569333 Lot 25LDA072 ACC011088 UDI-DI 10198459589577 Lots 26BDA548 26GDA090 ACC011067 UDI-DI 10198459529184 Lots 25KDA639 25LDA980 26CDB158 DYKM1564 UDI-DI 10889942754571 Lots 24HBW937 24JBX634 24LBR085 25GBH209 25IBK590 25LBD525 26ABI524 26BBM585 26DBC555 DYKM1564A UDI-DI 10198459805165 Lot 26FBK649 DYNJT10325 UDI-DI 10198459787324 Lots 26EBM250 26FBA470 26FBF055 26FBH553 26FBH554 DYKS1089B UDI-DI 10193489306286 Lots 24JMG846 24LMD918 25GMD759 25GMK431 25IMF050 25KMJ026 26BMC073 26DMI048 DYNJ63410 UDI-DI 10193489737431 Lots 24LDB851 25BDA890 DYNDH1363 UDI-DI 10888277795464 Lots 24IBH349 24IBS200 24JBQ160 24KBN447 24LBG380 24LBI547 25ABW563 25DBH954 25GBD824 25HBT172 25IBO192 25JBB921 25JBQ987 ACC010770 UDI-DI 10195327576998 Lots 25HDA878 25IDA087 25IDA817 25JDB317 25KDB340 25LDB061 26ADA012 26ADA159 26ADB380 26ADC072 26BDA633 26CDA678 DYNDH1591 UDI-DI 10193489497236 Lots 24JMA966 25GMD752 25LMJ154 26AME497 26BMA252 26DMI088 26EMH914 26FMH453 26FMK588 EDUC1043 UDI-DI 10195327425531 Lots 24KDA258 24KDA880 24KDA963 EDUC1043A UDI-DI 10198459334559 Lots 25FLA817 25GLA090 25KLA077 25KLA693 26CLB165 26CLB165Z 26ELA472 DYKM1496 UDI-DI 10889942636082 Lot 24KBL243 DYNDV2520 UDI-DI 10653160384045 Lot 2024111990
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

ALL 50 STATES
▸Full report

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

Recall #:
99404
Lot/product code:
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark Digital ECG. The Midmark Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 7817519 7817645, L1130587 V2967564 UDI-DI: 00841709121319, 08056732652491
Recalling firm:
Midmark Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

ALL 50 STATES
▸Full report

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

Recall #:
99404
Lot/product code:
Lot Code: This correction affects IQecg plugin software versions starting with v10 and prior to v10.1.0.18 installed on Midmark IQecg Digital ECG. The Midmark IQecg Digital ECG system information is provided below. The total quantities manufactured and distributed noted below are the combined IQecgs Digital ECG and Midmark Digital ECG systems. Serial Numbers: 480000 4820704 UDI-DI: 00841709100581, 00841709100321, 00841709100895, 00841709100901
Recalling firm:
Midmark Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2026

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

ALL 50 STATES
▸Full report

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

Recall #:
99561
Lot/product code:
DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2026

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.

ALL 50 STATES
▸Full report

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

Recall #:
99450
Lot/product code:
UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
Recalling firm:
Remel Europe Ltd.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0744-2026
Lot/product code:
Lot # V24010V1, Exp 3/31/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 17, 2026

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

Presence of Particulate Matter; identified as stainless steel

ALL 50 STATES
▸Full report

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

Recall #:
D-0743-2026
Lot/product code:
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Recalling firm:
Sunny Pharmtech Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

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-0726-2026
Lot/product code:
Lot #: 6133801, Exp. Date 01/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.

ALL 50 STATES
▸Full report

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

Recall #:
99423
Lot/product code:
UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, (01)00884838116764(21)99, 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(01)00884838116771(21… (truncated, 50974 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

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▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0738-2026
Lot/product code:
Lot: 25141585, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Presence of Particulate Matter: Hair was found in products

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▸Full report

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

Recall #:
D-0727-2026
Lot/product code:
Lot #: 6133436, Exp. Date 10/2028
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

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▸Full report

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

Recall #:
99422
Lot/product code:
UDI: (01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578, (01)00884838099241(21)324, (01)00884838099241(21)585, (01)00884838099241(21)332, (01)00884838099258(21)750, (01)00884838099241(21)312, (01)00884838099241(21)85, (01)00884838099258(21)409, (01)00884838085268(21)1023, (01)00884838099272(21)125, (01)00884838099272(21)127, (01)00884838099272(21)126, (01)00884838099272(21)122, (01)00884838099272(21)123, (01)00884838099258(21)295, (01)00884838099272(21)124, (01)00884838099272(21)120, (01)00884838099258(21)277, (01)00884838099258(21)262, (01)00884838099258(21)261, (01)00884838099258(21)272, (01)00884838099258(21)275, (01)00884838085367(21)547, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838085251(21)585, (01)00884838099258(21)1315, (01)00884838085268(21)645, (01)00884838085251(21)410, (01)00884838085268(21)646, (01)00884838099258(21)3526, 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(01)00884838099258(21)1692, (01)00884838085268(21)905, (01)00884838085367(21)147, (01)00884838099258(21)2778, (01)00884838085268(21)55, (01)00884838099258(21)44, (01)00884838099258(21)210, (01)00884838085268(21)992, (01)00884838085268(21)691, (01)00884838099258(21)2421, (01)00884838099258(21)2432, (01)00884838099258(21)287, (01)00884838099272(21)113, (01)00884838085268(21)848, (01)00884838085367(21)205, (01)00884838085268(21)809, (01)00884838099272(21)121, (01)00884838099241(21)1130, (01)00884838099258(21)3291, (01)00884838099241(21)1052, (01)00884838099258(21)2882, (01)00884838085268(21)1033, (01)00884838099258(21)3155, (01)00884838085268(21)891, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085268(21)836, (01)00884838099258(21)3211, (01)00884838099258(21)904, (01)00884838085268(21)1155, (01)00884838085268(21)466, (01)00884838085268(21)1157, (01)00884838099272(21)158, (01)00884838099258(21)403, (01)00884838099272(21)139, (01)00884838085268(21)1395, (01)00884838099272(21)1145, (01)00884838099272(21)1078, (01)00884838085268(21)703559… (truncated, 294787 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

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▸Full report

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

Recall #:
D-0728-2026
Lot/product code:
Lot #: 6130235, Exp. Date 02/2027
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0737-2026
Lot/product code:
Lot: 25141583, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0739-2026
Lot/product code:
Lot: 25141586, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

Presence of Particulate Matter: Hair was found in products

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-0729-2026
Lot/product code:
Lot #: 6133986, Exp. Date 02/2029
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

ALL 50 STATES
▸Full report

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

Recall #:
99459
Lot/product code:
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
Recalling firm:
Biofire Defense
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2026

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.

ALL 50 STATES
▸Full report

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

Recall #:
99441
Lot/product code:
UDI/DI 7630031707055, Lot ZVFV5
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 16, 2026

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Presence of Particulate Matter: Hair was found in product

ALL 50 STATES
▸Full report

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

Recall #:
D-0725-2026
Lot/product code:
Lot #: 6134349, 6134620 Exp. Date 11/2026
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2026

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

A software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

ALL 50 STATES
▸Full report

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

Recall #:
99436
Lot/product code:
1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)