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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

0 Class I (most serious) drug recalls reported in the last 30 days.

128 recalls

  • Class II Ongoing

    BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and C…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
    Lots / codes
    Lot: 4298581, expires: 09/30/2026.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    N/A
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0644-2026
  • Class II Ongoing

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applic…

    Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    1,800 units
    Recall started
    June 11, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0643-2026
  • Class I Ongoing

    BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di…

    Reason: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
    Lots / codes
    Lot # 4073005, Exp 03/31/2027
    Distribution
    Nationwide inthe USA, as well as other foreign distribution.
    Quantity
    178,000 applicators
    Recall started
    May 28, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0625-2026
  • Class I Ongoing

    BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of B…

    Reason: Non-Sterility: Due to presence of Aspergillus penicillioides.

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
    Lots / codes
    Lot # 4032183, Exp 01/31/2027
    Distribution
    Nationwide inthe USA, as well as other foreign distribution.
    Quantity
    193,440 applicators
    Recall started
    May 28, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0624-2026
  • Class II Ongoing

    BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di…

    Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
    Lots / codes
    Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 3293922, 3297295, 3298930, 3299555, 3299562, 3301403, 3304245, 3306751, 3307190, 3310919, 3310926, 3314371, Exp Date: 10/31/2026; Lot # 3319520, 3321408, 3321409, 3324363, 3324369, 3332082, 3334305, 3335243, 3336896, 3337416, 3337417, 3340134, 3343540, 3346461, Exp Date: 11/30/2026; Lot # 3347121, 3350902, 3353143, 4004043, 4008394, 4009336, 4011488, 4012213, Exp Date: 12/31/2026; Lot # 4017668, 4019659, 4024538, 4025597, 4028103, 4030830, 4031885, 4032130, 4034194, 4037955, 4039988, 4039341, 4042520, 4045073, Exp Date: 01/31/2027; Lot # 4045127, 4050288, 4053896, 4058398, 4060624, 4062561, 4066133, 4068918, 4070112, 4074981, 4075814, 4078276, Exp Date: 02/28/2027; Lot # 4072390, 4073005, 4079088, 4080879, 4081625, 4086628, 4087806, 4096981, 4100347, 4100349, 4103385, 4103386, 4110975, 4113747, 4131843, Exp Date: 03/31/2027; Lot # 4121050, 4123171, 4123172, 4128501, 4128502, 4130512, 4135272, Exp Date: 04/30/2027; Lot # 4141597, 4150024, 4149611, 4150025, 4152202, 4157691, 4159978, 4160566, 4163121, Exp Date: 05/31/2027; Lot # 4173445, 4173447, 4178299, 4178303, 4180764, 4193574, 4197392, 4200111, 4204425, Exp Date: 06/30/2027; Lot # 4205156, 4206764, 4206766, 4207230, 4213335, 4211319, 4215668, 4218795, 4220980, 4242090, Exp Date: 07/31/2027; Lot # 4226396, 4227235, 4229934, 4232786, 4236636, 4236982, 4236489, 4242092, 4242505, 4248359, 4250795, 4254763, Exp Date: 08/31/2027; Lot # 4256132, 4260191, 4261289, 4261760, 4262812, 4269519, 4270776, 4271977, 4274445, 4276054, 4282861, Exp Date: 09/30/2027; Lot # 4284334, 4290362, 4291615, 4297871, 4299657, 4300686, 4302997, 4303204, 4305323, 4305318, 4310195, 4311615, 4312855, 4313930, Exp Date: 10/31/2027.
    Distribution
    Nationwide inthe USA, as well as other foreign distribution.
    Quantity
    N/A
    Recall started
    May 28, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0623-2026
  • Class II Ongoing

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson…

    Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
    Lots / codes
    Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559, Exp Date: 1/31/2027; Lot # 4049128, 4060484, 4061622, 4062534, Exp Date: 02/28/2027; Lot # 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351, Exp Date: 03/31/2027; Lot # 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749, Exp Date: 04/30/2027; Lot # 4137704, 4139447, Exp Date: 05/31/2027
    Distribution
    Nationwide inthe USA, as well as other foreign distribution.
    Quantity
    N/A
    Recall started
    May 28, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0622-2026
  • Class II Ongoing

    Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.

    Reason: Microbial contamination of sterile products

    Zep Inc

    Lots, distribution and details
    Lots / codes
    Batch # E2612116, Exp Date: April 2029.
    Distribution
    US Nationwide.
    Quantity
    5 drums
    Recall started
    May 22, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0586-2026
  • Class II Ongoing

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becto…

    Reason: Lack of assurance of Sterility: potential product contamination

    CareFusion 213, LLC

    Lots, distribution and details
    Product
    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
    Lots / codes
    Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    April 22, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0518-2026
  • Class II Ongoing

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

    Reason: Lack of assurance of Sterility: potential product contamination

    CareFusion 213, LLC

    Lots, distribution and details
    Lots / codes
    Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    April 22, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0517-2026
  • Class II Ongoing

    Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good…

    Reason: Lack of Assurance of Sterility

    K.C. Pharmaceuticals, Inc

    Lots, distribution and details
    Product
    Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
    Lots / codes
    Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26.
    Distribution
    Nationwide in the US
    Quantity
    589,848 bottles
    Recall started
    March 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0416-2026
  • Class I Ongoing

    Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.

    Reason: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis

    Cardinal Health 200, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 25H065362; 25J013962; 25J034762; 25J064562; 25K004962; 25K041262; 25K065062; 25L015362; 25H065462; 25J014062; 25J035762; 25J064762; 25K005062; 25K041362; 25K065162; 25L015462; 25H066062; 25J014862; 25J035862; 25J064862; 25K006162; 25K041462; 25K065262; 25L015662; 25H066162; 25J014962; 25J035962; 25J064962; 25K006262; 25K041562; 25K065362; 25L016362; 25H066262; 25J033962; 25J050362; 25J065762; 25K006362; 25K041662; 25K064562; 25L015962; 25H066362; 25J034862; 25J050462; 25J066262; 25K005162; 25K040462; 25K064662; 25L016062; 25H066462; 25J034062; 25J050562; 25J066362; 25K006462; 25K040562; 25K065462; 25L030162; 25J013462; 25J034162; 25J050962; 25K004062; 25K019662; 25K040662; 25K065562; 25L058062; 25J013562; 25J034262; 25J051062; 25K004162; 25K020862; 25K040762; 25K065662; 25M022362; 25J014362; 25J034362; 25J051262; 25K005262; 25K020962; 25K040962; 25K066262; 25M028462; 25J014462; 25J034462; 25J051362; 25J065962; 25K019762; 25K041062; 25K066162; 25H065962; 25J034962; 25J051462; 25J065062; 25K019862; 25K041162; 25K064862; 25H065762; 25J035062; 25J051762; 25J065162; 25K021062; 25K041762; 25K065862; 25H065862; 25J035162; 25J051862; 25J066062; 25K021162; 25K041862; 25K079962; 25H066862; 25J035262; 25J051962; 25J066162; 25K021262; 25K041962; 25K080962; 25H066962; 25J035362; 25J075762;25K004262; 25K019962; 25K042162; 25K081062; 25J013162; 25J013662; 25J051162; 25K004362; 25K020062; 25K042262; 25K080062; 25J013262; 25J014562; 25J052062; 25K004462; 25K021362; 25K040862; 25K080162; 25J013362; 25J014662; 25J052162; 25K004562; 25K021462; 25K042062; 25K080262; 25J014162; 25J014762; 25J052262; 25K004662; 25K021562; 25K063862; 25K080362; 25J014262; 25J034562; 25J052362; 25K005362; 25K020162; 25K020562; 25K080462; 25H065562; 25J034662; 25J064362; 25K005462; 25K020262; 25K020362; 25K081162; 25H065662; 25J035462; 25J064462; 25K005562; 25K020662; 25K020462; 25K081262; 25H066562; 25J035562; 25J064662; 25K005662; 25K021662; 25K021962; 25K081362; 25H066662; 25J035662; 25J065262; 25K005762; 25K021762; 25K022062; 25K081462; 25H066762;25J050662; 25J065362; 25K004762; 25K021862; 25K063962; 25K081562; 25J012962; 25J050762; 25J065462; 25K004862; 25K040062; 25K064062; 25K080562; 25J013062; 25J050862; 25J065562; 25K005862; 25K040162; 25K064162; 25L014062; 25J013762; 25J051562; 25J065662; 25K005962; 25K040262; 25K064262; 25L014162; 25J013862; 25J051662; 25J065862; 25K006062; 25K040362; 25K064462; 25L015262 within Expiry
    Distribution
    Nationwide within the United States, Puerto Rico and Japan.
    Quantity
    174,380,282 boxes
    Recall started
    March 2, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0528-2026
  • Class II Ongoing

    Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0378-2026
  • Class II Ongoing

    Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN16022, Exp. Date Aug 2027; MN33922, MN31222, Exp. Date Apr 2027; MN16522, Exp. Date Oct 2027; MN17022, Exp. Date Apr 2027; MN03323, Exp. Date Jan 2028; MN34622, Exp. Date Oct 2027.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0368-2026
  • Class II Ongoing

    LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0284-2026
  • Class II Ongoing

    Swan, White Clear Alcohol, 50%, 16oz, 12 count

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0280-2026
  • Class II Ongoing

    BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

    Reason: Lack of Assurance of Sterlity

    CareFusion 213, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 5086623, Exp. Date 03/31/2028
    Distribution
    Nationwide within the United States
    Quantity
    106,400 units
    Recall started
    December 17, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0243-2026
  • Class II Ongoing

    San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

    Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

    DermaRite Industries, LLC

    Lots, distribution and details
    Lots / codes
    All lots on or before expiry date 08/2027
    Distribution
    Nationwide in the USA
    Quantity
    15,465 cartridges
    Recall started
    August 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0176-2026
  • Class II Ongoing

    GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries…

    Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

    DermaRite Industries, LLC

    Lots, distribution and details
    Product
    GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Lots / codes
    All lots on or before expiry date 08/2027
    Distribution
    Nationwide in the USA
    Quantity
    115,994 containers
    Recall started
    August 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0166-2026
  • Class II Ongoing

    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 6…

    Reason: Subpotent Drug

    Medline Industries, LP

    Lots, distribution and details
    Product
    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
    Lots / codes
    Lot #: 61224040057
    Distribution
    Nationwide within the United States
    Quantity
    222,800 eaches
    Recall started
    September 29, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0035-2026
  • Class II Ongoing

    AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4×1 Gallon Case, 5 Gallon Pail, 55 G…

    Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

    Acuity Specialty Products, Inc.

    Lots, distribution and details
    Product
    AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4×1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
    Lots / codes
    Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    September 29, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0005-2026
  • Class II Ongoing

    Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000m…

    Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

    Acuity Specialty Products, Inc.

    Lots, distribution and details
    Product
    Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4×1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
    Lots / codes
    Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    September 29, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0004-2026
  • Class III Ongoing

    TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14

    Reason: Cross Contamination with Other Products.

    Consumer Product Partners, LLC

    Lots, distribution and details
    Product
    TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
    Lots / codes
    Lot 0662036; Exp Date 06/19/2027
    Distribution
    US Nationwide.
    Quantity
    60 bottles
    Recall started
    August 25, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0661-2025
  • Class III Ongoing

    Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14

    Reason: Cross Contamination with Other Products.

    Consumer Product Partners, LLC

    Lots, distribution and details
    Product
    Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
    Lots / codes
    Lot 0662036; Exp. Date 06/19/2027
    Distribution
    US Nationwide.
    Quantity
    1860 bottles
    Recall started
    August 25, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0660-2025
  • Class II Ongoing

    Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.

    Reason: cGMP Deviations

    YANGZHOU YULOU PAPER PRODUCTS CO., LTD

    Lots, distribution and details
    Lots / codes
    Lot #: 20240610, Exp. Date 06/2029
    Distribution
    N/A
    Quantity
    500 cases
    Recall started
    July 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0659-2025
  • Class II Ongoing

    RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.

    Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

    MEDLINE INDUSTRIES, LP – Northfield

    Lots, distribution and details
    Lots / codes
    61224070083
    Distribution
    Nationwide
    Quantity
    984,000 pads
    Recall started
    July 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0605-2025

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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