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Recalls affecting Kansas

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

16,731 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 10, 2026

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825006877, Lot Numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825005528, Lot Numbers: 3495675, 4117216, 4330131, 4471121, 4553575, 4630179, 4768595, 4821705, 4954755, 5043512, 3684287, 4129638, 4334639, 4471122, 4554838, 4630180, 4773075, 4821706, 4954759, 5043513, 3691298, 4145046, 4334644, 4474949, 4555860, 4634858, 4793018, 4821707, 4961661, 5043514, 3763763, 4150788, 4334650, 4474951, 4556028, 4634859, 4793019, 4821708, 4971101, 5043515, 3775492, 4175981, 4355098, 4474952, 4569198, 4634860, 4793020, 4822439, 4971102, 5043518, 3775494, 4179878, 4359156, 4479369, 4569199, 4635785, 4793021, 4822440, 4973758, 5045769, 3784070, 4184227, 4359191, 4479371, 4569215, 4635862, 4793022, 4822455, 4974714, 5045901, 3792331, 4186482, 4359418, 4483403, 4570262, 4640440, 4794757, 4830178, 4976272, 5050564, 3794912, 4188323, 4367362, 4483440, 4576849, 4640444, 4794787, 4830179, 4976273, 5050565, 3794915, 4188326, 4367363, 4484604, 4581614, 4645476, 4794789, 4830180, 4976274, 5050573, 3812435, 4201950, 4375667, 4484728, 4583794, 4649445, 4795050, 4830611, 4976275, 5052378, 3822411, 4206043, 4375668, 4484730, 4583795, 4649447, 4795052, 4837569, 4981738, 5056092, 3828557, 4217802, 4375670, 4494938, 4590093, 4666121, 4798012, 4841236, 4981739, 5056098, 3834570, 4223058, 4379438, 4500899, 4599370, 4670683, 4798893, 4842482, 4981741, 5056146, 3856651, 4223059, 4385998, 4500900, 4601759, 4670686, 4798894, 4849535, 4981743, 5056156, 3860662, 4226233, 4386193, 4500901, 4604044, 4670692, 4798895, 4849538, 4983562, 5056157, 3900656, 4234978, 4386196, 4524162, 4606184, 4670695, 4798896, 4854912, 4985073, 5056158, 3947356, 4246621, 4386199, 4528392, 4607129, 4684581, 4798897, 4858801, 4985074, 5056159, 3980664, 4247945, 4386213, 4528394, 4608446, 4689653, 4798898, 4858803, 4985075, 5071158, 3989350, 4252214, 4386219, 4530056, 4614402, 4690469, 4798899, 4858807, 4999738, 5071162, 4004245, 4254255, 4386220, 4530068, 4615032, 4733158, 4803865, 4865777, 5018016, 5073737, 4014734, 4254258, 4390069, 4530069, 4615533, 4733159, 4804015, 4866488, 5018018, 5073738, 4018502, 4262594, 4390076, 4533342, 4615535, 4733161, 4807052, 4866489, 5018019, 5073739, 4057460, 4275962, 4405109, 4534882, 4616911, 4733162, 4813125, 4866513, 5018022, 5073740, 4058912, 4277371, 4406133, 4534883, 4616912, 4733163, 4813133, 4873157, 5018023, 5077981, 4074970, 4282261, 4406134, 4539283, 4618308, 4737222, 4813140, 4873158, 5018498, 5077982, 4081932, 4287761, 4427706, 4539287, 4619851, 4745906, 4817687, 4875001, 5021780, 5077984, 4084034, 4294841, 4435823, 4539290, 4619854, 4745907, 4817689, 4883359, 5038794, 5081366, 4095939, 4302829, 4452359, 4539291, 4619856, 4745908, 4817690, 4896357, 5042549, 5087199, 4097365, 4325230, 4459673, 4553565, 4619863, 4764244, 4817693, 4945462, 5043510, 4097366, 4325232, 4464301, 4553566, 4621608, 4767000, 4821704, 4954754, 5043511.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825003739, Lot Numbers 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, 5056828.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825006815, Lot Numbers: 2696145, 3794476, 4262195, 4633829, 4786916, 4849947, 5002352, 2965551, 3812493, 4265992, 4637189, 4792723, 4850691, 5002356, 3152561, 3814730, 4299204, 4637394, 4792893, 4851631, 5002359, 3172403, 3816485, 4337701, 4638269, 4793417, 4851632, 5002471, 3214127, 3851379, 4337958, 4639992, 4793418, 4851633, 5002472, 3229881, 3851380, 4345121, 4640104, 4794109, 4851635, 5008611, 3231417, 3851381, 4347049, 4640298, 4794112, 4862174, 5011458, 3312354, 3856993, 4352168, 4640299, 4794113, 4862621, 5017279, 3391553, 3859715, 4385951, 4644671, 4795044, 4865853, 5017489, 3419988, 3872508, 4395928, 4644672, 4795045, 4867603, 5027374, 3529291, 3895749, 4414258, 4645668, 4797291, 4867987, 5030307, 3535239, 3895751, 4419159, 4645812, 4797920, 4971117, 5031793, 3562006, 3895752, 4423479, 4647311, 4797924, 4971944, 5031878, 3582655, 3901375, 4425060, 4653274, 4797926, 4971947, 5032321, 3603300, 3918234, 4431614, 4664276, 4797930, 4971948, 5032386, 3636415, 3920888, 4437406, 4670462, 4799499, 4974025, 5034496, 3651834, 3937237, 4441090, 4670679, 4801581, 4979034, 5034497, 3655196, 3960672, 4458892, 4670680, 4807674, 4980507, 5034498, 3656249, 3970969, 4462985, 4672993, 4808182, 4980530, 5038587, 3658257, 3991875, 4473952, 4672995, 4808183, 4982050, 5038588, 3665444, 4012832, 4479589, 4672996, 4815394, 4984123, 5043499, 3677212, 4012885, 4481147, 4732567, 4815398, 4984126, 5043827, 3694515, 4071638, 4483708, 4732568, 4815399, 4984748, 5044555, 3709365, 4075854, 4486102, 4735809, 4816696, 4986997, 5044556, 3709396, 4088027, 4486103, 4735812, 4818303, 4986998, 5044557, 3710574, 4090987, 4497350, 4735814, 4818304, 4987268, 5044558, 3727131, 4095290, 4502986, 4735987, 4818306, 4987269, 5057014, 3728355, 4095510, 4502987, 4735988, 4818307, 4987270, 5080098, 3729486, 4097587, 4503631, 4735990, 4819692, 4992590, 5081266, 3747071, 4106743, 4523798, 4738428, 4819695, 4993071, 5081365, 3761145, 4108814, 4523801, 4740253, 4822574, 4993684, 5082367, 3763791, 4115879, 4533536, 4740739, 4826934, 4993689, 5082368, 3763855, 4119335, 4540396, 4741159, 4826935, 4993880, 5082369, 3763856, 4123513, 4549484, 4741160, 4826937, 4993881, 5082370, 3764216, 4149187, 4579089, 4744238, 4826938, 4993882, 5085317, 3770102, 4152148, 4597761, 4744239, 4828151, 4993883, 5085403, 3773860, 4175762, 4608379, 4745443, 4830359, 4993884, 5085404, 3774100, 4177955, 4608381, 4745445, 4833592, 4993885, 5085405, 3787685, 4178577, 4608382, 4749733, 4833593, 4998125, 5085406, 3790359, 4178582, 4610179, 4764854, 4834330, 4998610, 3794458, 4185882, 4613525, 4766335, 4834331, 4998611, 3794460, 4189493, 4615091, 4785653, 4834332, 4998612, 3794462, 4213206, 4624363, 4786265, 4840666, 4999415, 3794467, 4233873, 4630474, 4786266, 4845709, 5002341, 3794473, 4236800, 4631218, 4786915, 4849946, 5002349.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

ALL 50 STATES
Full report

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

Recall #:
98745
Lot/product code:
REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825007355, Lot Numbers: 4248065, 4625922, 4792899, 4880229, 4947722, 4982083, 5004927, 5022043, 5031874, 5063926, 4253253, 4642049, 4798611, 4880230, 4950352, 4982089, 5004930, 5022044, 5032223, 5063929, 4253255, 4643022, 4804375, 4880231, 4950943, 4982090, 5008468, 5022045, 5032225, 5063931, 4282439, 4650872, 4804411, 4880233, 4950945, 4982091, 5008470, 5022046, 5032226, 5063932, 4369559, 4651469, 4804956, 4880370, 4950946, 4982093, 5008499, 5022051, 5032227, 5063933, 4386017, 4654912, 4808755, 4880374, 4950947, 4982094, 5008537, 5022052, 5033028, 5068012, 4459470, 4666108, 4811587, 4880582, 4950948, 4982095, 5009357, 5022053, 5033804, 5068846, 4464828, 4670429, 4815453, 4880586, 4950949, 4982097, 5012821, 5022055, 5033805, 5070828, 4486895, 4674208, 4816333, 4880587, 4952904, 4983512, 5012842, 5022056, 5034675, 5070908, 4486907, 4674212, 4818581, 4880588, 4952911, 4987173, 5017443, 5022057, 5035406, 5070909, 4487361, 4674869, 4820929, 4880719, 4953421, 4987174, 5019148, 5022060, 5036552, 5071507, 4487365, 4676135, 4820938, 4880721, 4962172, 4987470, 5020249, 5022062, 5039336, 5071508, 4488481, 4679712, 4820950, 4880722, 4963232, 4987471, 5020250, 5022063, 5039339, 5071509, 4490405, 4686708, 4821064, 4880723, 4963402, 4990374, 5020251, 5022066, 5043250, 5071512, 4495375, 4721283, 4824114, 4881023, 4963403, 4990903, 5020253, 5022067, 5045299, 5072178, 4509673, 4733888, 4824179, 4881051, 4963404, 4990904, 5020258, 5024944, 5050759, 5073644, 4521315, 4733892, 4825854, 4881630, 4967560, 4990911, 5020260, 5025536, 5050796, 5073650, 4521322, 4735180, 4825857, 4883295, 4967561, 4992059, 5020261, 5025704, 5053080, 5073655, 4541213, 4743109, 4826624, 4883342, 4967562, 4992464, 5020262, 5025723, 5054956, 5073656, 4541214, 4746540, 4826633, 4883555, 4967563, 4992467, 5020271, 5026509, 5054958, 5075343, 4541215, 4748739, 4826637, 4883556, 4967564, 4992530, 5020274, 5029335, 5054961, 5076771, 4541217, 4750664, 4826641, 4883557, 4967924, 4992531, 5020276, 5029336, 5054962, 5076775, 4541218, 4752092, 4830154, 4883558, 4968645, 4993543, 5020277, 5029338, 5054963, 5076811, 4541559, 4752135, 4831909, 4883562, 4968922, 4993546, 5020282, 5029339, 5054964, 5076815, 4541712, 4753709, 4848437, 4884368, 4968949, 4993744, 5020284, 5029340, 5054965, 5076817, 4541714, 4756256, 4850164, 4884775, 4969151, 4994177, 5020288, 5029341, 5054967, 5077002, 4545192, 4758701, 4856808, 4884777, 4969161, 4994719, 5021665, 5029342, 5056149, 5082665, 4556354, 4758702, 4856813, 4890996, 4974122, 4994890, 5022029, 5029365, 5056460, 5083385, 4596982, 4762175, 4863997, 4938389, 4974141, 4994891, 5022030, 5029366, 5056461, 5083391, 4600390, 4766874, 4863998, 4938390, 4974446, 4996402, 5022031, 5029367, 5056462, 5083394, 4600391, 4770302, 4863999, 4938391, 4980581, 5000019, 5022032, 5029770, 5056463, 5085411, 4600411, 4770806, 4864006, 4938392, 4981030, 5002189, 5022033, 5029771, 5059995, 5086657, 4600413, 4770963, 4865883, 4939498, 4981031, 5002192, 5022034, 5029773, 5060182, 5087306, 4600416, 4772466, 4869245, 4940696, 4981032, 5002193, 5022035, 5030905, 5060183, 4600419, 4774260, 4875724, 4940950, 4981034, 5002940, 5022037, 5031786, 5061556, 4601678, 4774598, 4880219, 4945464, 4981035, 5004185, 5022038, 5031848, 5062679, 4602555, 4777179, 4880220, 4945474, 4982075, 5004922, 5022039, 5031849, 5063808, 4603539, 4778432, 4880222, 4945903, 4982077, 5004923, 5022040, 5031850, 5063831, 4607203, 4780896, 4880226, 4947019, 4982079, 5004924, 5022041, 5031872, 5063902, 4624545, 4781757, 4880228, 4947020, 4982082, 5004926, 5022042, 5031873, 5063917.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825007331. Lot Numbers: 3557411, 3702628, 4498116.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825011529, Lot Numbers: 3881385, 4808385, 4854113, 4961672, 4974217, 4988584, 4993237, 5016458, 5021634, 5048549, 3921444, 4822971, 4945780, 4961673, 4979107, 4988587, 4994122, 5016460, 5021635, 5050589, 3998693, 4822986, 4945781, 4961674, 4981313, 4988751, 4994128, 5016461, 5021636, 5053395, 4029481, 4822987, 4953683, 4970070, 4982419, 4988752, 4994180, 5016462, 5021637, 5053396, 4369183, 4824246, 4954241, 4970071, 4982421, 4988753, 4998213, 5016463, 5021639, 5060170, 4369245, 4824248, 4961385, 4970361, 4983569, 4988754, 4998214, 5016464, 5021640, 5060171, 4732484, 4824249, 4961665, 4970362, 4986061, 4988755, 5005259, 5016466, 5021641, 5060172, 4751084, 4828822, 4961666, 4970363, 4986062, 4988756, 5005263, 5017692, 5025098, 5060173, 4796276, 4837793, 4961667, 4970364, 4986063, 4990589, 5005264, 5017935, 5025100, 5060174, 4798223, 4846389, 4961668, 4970365, 4986064, 4990590, 5011152, 5018675, 5025101, 5086587, 4801020, 4853335, 4961669, 4970366, 4986065, 4990591, 5014700, 5018677, 5036101, 5086588, 4801021, 4853336, 4961670, 4970367, 4986067, 4990592, 5014702, 5020792, 5042591, 5086590, 4808376, 4854112, 4961671, 4970368, 4986068, 4992498, 5016457, 5021633, 5045829, 5086592.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

ALL 50 STATES
Full report

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

Recall #:
98837
Lot/product code:
Medline Kit SKU DYNJRA9026: UDI/DI 10884389285688 each, 40884389285689, case, Lot Numbers: 26BBD235, 26ABB534, 25DBT837, 25CBH118, 24FBT403, 24FBJ505.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 07613327357301, Lot Numbers: 2934107, 3695884, 3813841, 3963557, 4293648, 4660245, 4816422, 4937844, 4984006, 5024442, 2964378, 3695885, 3813842, 3963558, 4294641, 4665924, 4816423, 4937846, 4984751, 5024443, 3369649, 3695886, 3813843, 3963559, 4320451, 4665926, 4820652, 4937850, 4985810, 5025866, 3414030, 3695889, 3813844, 3963561, 4320454, 4677505, 4824140, 4937853, 4985813, 5025908, 3487957, 3695898, 3814084, 3963565, 4320584, 4683574, 4824141, 4937876, 4985814, 5025909, 3487959, 3695899, 3814089, 3963923, 4320585, 4690460, 4824142, 4937886, 4985819, 5025913, 3516565, 3695905, 3814090, 3965856, 4352366, 4690461, 4824143, 4937914, 4985820, 5030283, 3516579, 3695909, 3814151, 3971195, 4365471, 4722597, 4824144, 4937921, 4985977, 5030284, 3533495, 3695911, 3814152, 3971196, 4365472, 4722598, 4825584, 4937937, 4985978, 5030285, 3536146, 3695912, 3814379, 3971197, 4371818, 4734903, 4825590, 4938070, 4985980, 5030306, 3563129, 3713425, 3814402, 3971199, 4380641, 4742839, 4828929, 4938075, 4986540, 5030308, 3623660, 3720912, 3814403, 3971200, 4384663, 4770976, 4829405, 4940572, 4990713, 5030309, 3635399, 3720913, 3814404, 3971363, 4384664, 4770977, 4829407, 4940573, 4990727, 5034157, 3639136, 3720914, 3814405, 3991716, 4384665, 4774463, 4829408, 4940574, 4992829, 5034251, 3642928, 3720915, 3814406, 4000629, 4384666, 4774464, 4829409, 4940575, 4998446, 5036560, 3657002, 3720916, 3814407, 4018409, 4384667, 4776002, 4830745, 4952872, 4998448, 5036561, 3657003, 3720919, 3814408, 4020134, 4384668, 4776023, 4830748, 4953149, 4998547, 5040068, 3658634, 3733771, 3814409, 4068043, 4390632, 4799861, 4833289, 4953150, 4998548, 5041755, 3658673, 3741542, 3814410, 4111059, 4400780, 4799862, 4840236, 4953151, 5002404, 5041756, 3659104, 3743987, 3824661, 4115291, 4406069, 4799863, 4841977, 4953153, 5002405, 5041760, 3665462, 3748109, 3824662, 4142838, 4423866, 4800152, 4841978, 4953154, 5002602, 5043056, 3665463, 3766803, 3831087, 4142840, 4423870, 4800155, 4842198, 4953155, 5002603, 5043824, 3665464, 3766807, 3841170, 4142841, 4428699, 4800353, 4842783, 4953156, 5002604, 5043825, 3665465, 3766808, 3843536, 4144673, 4428700, 4801216, 4846033, 4953157, 5002605, 5052577, 3665466, 3770489, 3845330, 4144997, 4438106, 4806963, 4852908, 4953162, 5008310, 5059783, 3670655, 3774007, 3851621, 4181100, 4450156, 4806964, 4854158, 4953183, 5008392, 5059784, 3670656, 3778766, 3851622, 4181101, 4495768, 4806965, 4855585, 4953184, 5008394, 5059785, 3670659, 3778767, 3851623, 4181102, 4498972, 4806966, 4855586, 4960862, 5008412, 5059786, 3670662, 3778769, 3851624, 4199249, 4500710, 4808371, 4855669, 4973101, 5008704, 5059787, 3670665, 3788271, 3851625, 4200117, 4512636, 4811617, 4859421, 4973653, 5008705, 5059788, 3670666, 3792023, 3851626, 4218160, 4519621, 4813305, 4859422, 4978434, 5008750, 5059789, 3684410, 3805982, 3888520, 4225232, 4548019, 4813306, 4865886, 4978435, 5008751, 5067006, 3684411, 3809170, 3888521, 4232774, 4593743, 4813307, 4868858, 4979809, 5017528, 5078231, 3684412, 3809184, 3888524, 4265339, 4617777, 4813310, 4871606, 4979810, 5017529, 5078232, 3691269, 3809306, 3895233, 4265852, 4623978, 4813611, 4871607, 4980427, 5017533, 5081439, 3693634, 3809307, 3944996, 4281497, 4636786, 4813612, 4871608, 4980429, 5017536, 5081440, 3695835, 3811477, 3944997, 4281516, 4637499, 4814211, 4871609, 4980430, 5017539, 5081441, 3695836, 3811480, 3944998, 4281899, 4643511, 4814213, 4871610, 4980836, 5017541, 5083240, 3695850, 3813705, 3953668, 4282025, 4651653, 4814221, 4872209, 4980837, 5021604, 5083242, 3695852, 3813706, 3960483, 4282026, 4653186, 4814228, 4937761, 4980838, 5021606, 5085978, 3695865, 3813707, 3963551, 4282027, 4655459, 4814231, 4937764, 4980870, 5021607, 3695866, 3813708, 3963553, 4282248, 4656625, 4816416, 4937771, 4982864, 5022826, 3695873, 3813709, 3963555, 4282965, 4659207, 4816418, 4937832, 4984004, 5024439, 3695876, 3813839, 3963556, 4292165, 4659209, 4816419, 4937843, 4984005, 5024440.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825007300, Lot Numbers: 1772607, 3994138, 4539200, 4808444, 4985924, 5010522, 5042942, 2482952, 4046485, 4539206, 4808677, 4986242, 5010524, 5042944, 2521570, 4164020, 4540476, 4812775, 4986243, 5017909, 5042945, 2521636, 4166570, 4544644, 4817888, 4986244, 5018848, 5043881, 2521660, 4182322, 4549452, 4824089, 4986245, 5020135, 5043883, 2577590, 4183176, 4549458, 4824092, 4986256, 5020136, 5052391, 2711877, 4206584, 4549460, 4824093, 4986399, 5020139, 5056580, 2769403, 4216286, 4551863, 4825561, 4993904, 5020147, 5060152, 2769695, 4247577, 4567736, 4830114, 4993905, 5020149, 5060153, 2787951, 4260013, 4569285, 4833151, 4993910, 5020453, 5060154, 2919616, 4274184, 4569297, 4850593, 4993912, 5024412, 5060155, 2919619, 4275872, 4569532, 4854631, 4993914, 5024413, 5060156, 2919623, 4287229, 4569539, 4854632, 4993915, 5025667, 5060157, 2986771, 4295030, 4577350, 4861162, 4993916, 5029412, 5060158, 3186438, 4390731, 4579539, 4861163, 4993920, 5032327, 5060159, 3269091, 4414236, 4665004, 4861164, 4997912, 5032328, 5060160, 3364168, 4414244, 4671456, 4868220, 4999701, 5032329, 5080121, 3371014, 4461334, 4675658, 4890809, 4999901, 5032330, 5080812, 3371015, 4477262, 4677973, 4950295, 5001378, 5032331, 5081406, 3371464, 4487544, 4734148, 4972469, 5001380, 5033613, 5081407, 3372123, 4487545, 4735713, 4974049, 5003013, 5035986, 5085275, 3398046, 4495634, 4739300, 4974050, 5003014, 5038644, 5085394, 3411209, 4508984, 4748755, 4976259, 5003015, 5038647, 5085395, 3413279, 4539190, 4756237, 4976293, 5003016, 5041264, 5085396, 3469626, 4539191, 4771668, 4985775, 5003017, 5042936, 5085889, 3499568, 4539192, 4792718, 4985776, 5003018, 5042937, 3784873, 4539196, 4804384, 4985921, 5003019, 5042940, 3896863, 4539199, 4808394, 4985922, 5008867, 5042941.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825007324, Lot Numbers: 4101996, 4175347.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI00885825011260, Lot Numbers: 4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, 4470118, 4778468, 4848976, 4966193, 4999115, 5029362, 5063586, 4490754, 4796800, 4855294, 4966194, 5002565, 5029363, 5068369, 4509009, 4815121, 4866012, 4966195, 5002566, 5029364, 5076464, 4527883, 4815122, 4874149, 4969132, 5002873, 5029535, 5085337, 4655115, 4820151, 4883354, 4973129, 5009392, 5029698, 5085818, 4720484, 4826777, 4890964, 4981099, 5014818, 5032181, 4730762, 4845060, 4940777, 4982418, 5017600, 5032182, 4754876, 4846853, 4941142, 4987516, 5018180, 5039989, 4758759, 4847494, 4948941, 4989050, 5018181, 5044865.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 10, 2026

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

ALL 50 STATES
Full report

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

Recall #:
98708
Lot/product code:
UDI 00885825003838, Lot Numbers: 4225215, 4653836, 4793147, 4852429, 4986000, 5023873, 5043553, 4280561, 4672798, 4799184, 4852603, 4986001, 5023874, 5043556, 4287896, 4677462, 4799186, 4854910, 4986002, 5023875, 5043560, 4296580, 4677463, 4799187, 4856657, 4997834, 5023876, 5053722, 4309622, 4693434, 4799188, 4860078, 5003556, 5027296, 5059498, 4309623, 4693435, 4799191, 4860082, 5003557, 5027297, 5059499, 4309846, 4693436, 4799309, 4861298, 5003558, 5027301, 5064680, 4374217, 4693437, 4800061, 4861536, 5003569, 5027406, 5064916, 4396650, 4728693, 4800062, 4939136, 5004167, 5027407, 5071434, 4458557, 4728695, 4800113, 4953662, 5004181, 5027571, 5072250, 4479919, 4733707, 4801993, 4953663, 5007874, 5028963, 5073207, 4497169, 4755043, 4801994, 4963413, 5009259, 5030330, 5073552, 4507933, 4755045, 4807495, 4963414, 5013933, 5031863, 5083312, 4510607, 4755046, 4808706, 4963418, 5013934, 5032745, 5083313, 4551972, 4755047, 4808707, 4966281, 5013949, 5038102, 5084295, 4566389, 4762910, 4809527, 4968920, 5013956, 5038314, 5085197, 4585687, 4773741, 4811620, 4968921, 5016583, 5038317, 4600586, 4777739, 4811622, 4974743, 5016616, 5038318, 4613364, 4786928, 4811625, 4976214, 5018038, 5038321, 4613429, 4786931, 4829506, 4976215, 5018718, 5038782, 4614815, 4793146, 4829507, 4985998, 5020889, 5043552.
Recalling firm:
Stryker Sustainability Solutions
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 9, 2026

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

Due to nonconforming products being inadvertently distributed.

ALL 50 STATES
Full report

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

Recall #:
98696
Lot/product code:
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 9, 2026

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

Failed Capsule Specifications: not meeting quality requirements results obtained during routine stability testing for Loss on Drying of Capsule Shells.

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-0493-2026
Lot/product code:
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Recalling firm:
The Harvard Drug Group LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

ALL 50 STATES
Full report

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

Recall #:
98566
Lot/product code:
"Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 8, 2026

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

ALL 50 STATES
Full report

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

Recall #:
98566
Lot/product code:
"[Model No.; UDI]: [3DM-SYS-INTL2D;15420045510609], [3DM-SYS-INTL2D-MOB;15420045510593], [3DM-SYS-INTL2D-NS;15420045510586], [3DM-SYS-INTL3D;15420045510579], [3DM-SYS-INTL3D-MOB;15420045510562], [3DM-SYS-INTL3D-NS;15420045510555], [3DM-SYS-STD;15420045510524], [3DM-SYS-STD-MOB;15420045510531], [3DM-SYS-STD-NS;15420045510548]; All Serial No.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 8, 2026

vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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-0696-2026
Lot/product code:
Lot BL3462, Exp. 2/7/2027
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled April 8, 2026

Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

ALL 50 STATES
Full report

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

Recall #:
D-0692-2026
Lot/product code:
Lot#: BL3608, Exp. 07/01/28.
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 8, 2026

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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-0698-2026
Lot/product code:
Lot BL3572, Exp 04/16/2028
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 8, 2026

TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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-0695-2026
Lot/product code:
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Recalling firm:
Blaine Labs Inc
View official FDA record (opens in a new tab)