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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

    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.)…

    Reason: CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    Adam's Polishes LLC

    Lots, distribution and details
    Product
    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
    Lots / codes
    Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327
    Distribution
    Nationwide in the USA
    Quantity
    3,441 gallons total
    Recall started
    November 5, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0067-2023
  • Class I Ongoing

    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.)…

    Reason: Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.

    Adam's Polishes LLC

    Lots, distribution and details
    Product
    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
    Lots / codes
    Lot: 133475
    Distribution
    Nationwide in the USA
    Quantity
    3,441 gallons total
    Recall started
    November 5, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0066-2023
  • Class II Ongoing

    Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.

    Reason: Labeling: Product Contains Undeclared API – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Lots / codes
    Lot # 015, 016, 017, 018, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 036, 037, 038.
    Distribution
    Distributed in VA, USA
    Quantity
    350,000 bottles
    Recall started
    July 19, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1475-2022
  • Class II Ongoing

    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

    Reason: Labeling: Product Contains Undeclared API – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Product
    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
    Lots / codes
    Lot # 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, 329, 330, 331, 332, 333, 334, 335, 336, 337, 338.
    Distribution
    Distributed in VA, USA
    Quantity
    2,700,000 bottles
    Recall started
    July 19, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1474-2022
  • Class II Ongoing

    READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999747 READY IN CASE 91PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999742 READY IN CASE 70PCT ISOPROPYL ALCOHOL 16 FL OZ…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999747 READY IN CASE 91PCT ISOPROPYL ALCOHOL 32 FL OZ SKU 999742 READY IN CASE 70PCT ISOPROPYL ALCOHOL 16 FL OZ SKU 999743 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 902270; 999747; 999742; 999743
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1422-2022
  • Class II Ongoing

    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668

    Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

    AMS Packaging Inc

    Lots, distribution and details
    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
    Lots / codes
    all lots
    Distribution
    Nationwide in the USA
    Quantity
    unknown
    Recall started
    May 10, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1148-2022
  • Class II Ongoing

    Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc.…

    Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

    A.P. Nonweiler

    Lots, distribution and details
    Product
    Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
    Lots / codes
    Lot: 54931, No Expiration date.
    Distribution
    Distributed in States of WI and VA
    Quantity
    833 gallons
    Recall started
    May 11, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1142-2022
  • Class II Ongoing

    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

    Reason: Labeling – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Lots / codes
    Lot#:339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398 and 399
    Distribution
    USA Nationwide
    Quantity
    135.444 bottles
    Recall started
    February 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0636-2022
  • Class II Ongoing

    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765

    Reason: Labeling – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Lots / codes
    Lot#: 39,40,41,42,43,44 and 45
    Distribution
    USA Nationwide
    Quantity
    1.186.800 bottles
    Recall started
    February 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0635-2022
  • Class II Ongoing

    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.

    Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

    AMS Packaging Inc

    Lots, distribution and details
    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
    Lots / codes
    All lots within expiry and labelled as 'Made in the USA'
    Distribution
    Nationwide in the USA
    Quantity
    487,000 bottles
    Recall started
    January 28, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0647-2022
  • Class II Ongoing

    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, U…

    Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

    AMS Packaging Inc

    Lots, distribution and details
    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
    Lots / codes
    All lots within expiry and labelled as 'Made in the USA'
    Distribution
    Nationwide in the USA
    Quantity
    2,095,567 bottles
    Recall started
    January 28, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0646-2022
  • Class II Ongoing

    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200.…

    Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6 76753 00420 8 ,
    Lots / codes
    Lot No: E332020, E212020 "Best Buy": 5/21/2022
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    N/A
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0783-2021
  • Class II Ongoing

    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,

    Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
    Lots / codes
    Lot No: E212020, "Best Buy": 5/21/2022
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    N/A
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0782-2021
  • Class I Ongoing

    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1

    Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Lots / codes
    Lot No: E082020, "Best Buy": 5/21/2022
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    N/A
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0781-2021
  • Class I Ongoing

    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200,…

    Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,
    Lots / codes
    Lot No: E082020, "Best Buy": 5/21/2022
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    50,000 bottles
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0780-2021
  • Class II Ongoing

    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 1420…

    Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7
    Lots / codes
    Lot No: E372020, "Best Buy": 5/21/2022;
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    50,000 bottles
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0779-2021
  • Class II Ongoing

    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de…

    Reason: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    Global Sanitizers LLC

    Lots, distribution and details
    Product
    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8
    Lots / codes
    Lot No: GV4420205 Best By, 5/21/2022
    Distribution
    Product Distributed Nationwide in the USA
    Quantity
    50,000 bottles
    Recall started
    May 12, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0778-2021
  • Class I Ongoing

    Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

    Reason: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

    Ardil Comercial S.R.L.

    Lots, distribution and details
    Product
    Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587
    Lots / codes
    Batch Number # 079932-4611-05-J, exp. date May 2022
    Distribution
    Product was distributed to one client in NYC who further distributed the product.
    Quantity
    1,260 bottles
    Recall started
    June 22, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0691-2021
  • Class II Ongoing

    QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 7162…

    Reason: Subpotent

    HOYU(US) LOGISTICS INC

    Lots, distribution and details
    Product
    QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
    Lots / codes
    Lot # Q20200320, exp. date 03/19/2022
    Distribution
    Product was destroyed nationwide.
    Quantity
    30,880 bottles
    Recall started
    June 22, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0643-2021
  • Class II Ongoing

    Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

    Reason: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

    Sunstar Americas, Inc.

    Lots, distribution and details
    Lots / codes
    ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022
    Distribution
    Nationwide USA
    Quantity
    a) 1,021,914 bottles; b) 255,552 bottles
    Recall started
    December 28, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0222-2021
  • Class II Ongoing

    NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3

    Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

    Albek De Mexico S.A. De C.V.

    Lots, distribution and details
    Lots / codes
    Lots ending in 1001,1002, 1003, 1004, 1005.
    Distribution
    USA Nationwide
    Quantity
    4,598,788 bottles
    Recall started
    July 30, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0082-2021
  • Class II Ongoing

    Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597

    Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

    Albek De Mexico S.A. De C.V.

    Lots, distribution and details
    Lots / codes
    1931101AL
    Distribution
    USA Nationwide
    Quantity
    19,992 bottles
    Recall started
    July 30, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0081-2021
  • Class II Ongoing

    Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

    Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

    Albek De Mexico S.A. De C.V.

    Lots, distribution and details
    Lots / codes
    1931102AL
    Distribution
    USA Nationwide
    Quantity
    27,000 bottles
    Recall started
    July 30, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0080-2021
  • Class II Ongoing

    Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6

    Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

    Albek De Mexico S.A. De C.V.

    Lots, distribution and details
    Lots / codes
    1931104AL
    Distribution
    USA Nationwide
    Quantity
    2,760 bottles
    Recall started
    July 30, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0079-2021
  • Class II Ongoing

    NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620…

    Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

    Albek De Mexico S.A. De C.V.

    Lots, distribution and details
    Product
    NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
    Lots / codes
    all lots
    Distribution
    USA Nationwide
    Quantity
    1,441,548 bottles
    Recall started
    July 30, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0078-2021

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 November 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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