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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.

3,228 recalls

  • Class II Ongoing

    AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit – Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.

    Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Bell Pharmaceuticals, Inc

    Lots, distribution and details
    Product
    AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit – Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
    Lots / codes
    Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
    Distribution
    U.S Nationwide
    Quantity
    5,762 units
    Recall started
    June 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0682-2026
  • Class II Ongoing

    TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit – WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

    Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Bell Pharmaceuticals, Inc

    Lots, distribution and details
    Lots / codes
    Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
    Distribution
    U.S Nationwide
    Quantity
    16,156 units
    Recall started
    June 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0681-2026
  • Class II Ongoing

    QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

    Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Bell Pharmaceuticals, Inc

    Lots, distribution and details
    Lots / codes
    Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.
    Distribution
    U.S Nationwide
    Quantity
    15, 843 units
    Recall started
    June 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0680-2026
  • Class II Ongoing

    Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Pra…

    Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Bell Pharmaceuticals, Inc

    Lots, distribution and details
    Product
    Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
    Lots / codes
    Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.
    Distribution
    U.S Nationwide
    Quantity
    29, 474 units
    Recall started
    June 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0679-2026
  • Class II Ongoing

    CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

    Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Bell Pharmaceuticals, Inc

    Lots, distribution and details
    Lots / codes
    Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
    Distribution
    U.S Nationwide
    Quantity
    106,301 units
    Recall started
    June 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0678-2026
  • Class II Ongoing

    Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

    Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

    Padagis US LLC · Nystatin

    Lots, distribution and details
    Lots / codes
    Lot #: 205060, Exp 09/30/2027
    Distribution
    USA Nationwide
    Quantity
    180,936 tubes
    Recall started
    June 23, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0677-2026
  • Class II Ongoing

    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Ku…

    Reason: cGMP deviations

    Shimoga Chemicals

    Lots, distribution and details
    Product
    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
    Lots / codes
    Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.
    Distribution
    CA & FL only
    Quantity
    N/A
    Recall started
    May 19, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0691-2026
  • Class II Ongoing

    Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

    Reason: Lack of Sterility Assurance

    Reliance Life Sciences Private Limited

    Lots, distribution and details
    Product
    Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
    Lots / codes
    Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027
    Distribution
    Nationwide in the USA
    Quantity
    8,001 vials
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0674-2026
  • Class II Ongoing

    Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01

    Reason: Lack of Sterility Assurance

    Reliance Life Sciences Private Limited

    Lots, distribution and details
    Lots / codes
    Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028
    Distribution
    Nationwide in the USA
    Quantity
    11,400 vials
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0673-2026
  • Class II Ongoing

    Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01

    Reason: Lack of Sterility Assurance

    Reliance Life Sciences Private Limited

    Lots, distribution and details
    Product
    Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
    Lots / codes
    Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
    Distribution
    Nationwide in the USA
    Quantity
    5,020 vials
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0672-2026
  • Class II Ongoing

    Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

    Reason: Lack of Sterility Assurance

    Reliance Life Sciences Private Limited

    Lots, distribution and details
    Product
    Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
    Lots / codes
    Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028
    Distribution
    Nationwide in the USA
    Quantity
    12,000 vials
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0671-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250206B1, 250218B2, 250507B1, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0670-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250109B1, 250110B1, 250228B1, 250303B1, 250304B1, 250305B1, 250306B1, 250306B2 within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0669-2026
  • Class II Ongoing

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250221A5, 250224A2 within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0668-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lot 250218B3, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0667-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0666-2026
  • Class II Ongoing

    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3

    Reason: Subpotent drug

    Gasco Industrial Corp.

    Lots, distribution and details
    Lots / codes
    Lot 250306B3, within expiry
    Distribution
    Nationwide within the US
    Quantity
    N/A
    Recall started
    May 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0665-2026
  • Class II Ongoing

    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

    Reason: Failed Impurities/Degradation Specifications

    QuVa Pharma, Inc. · Methohexital Sodium

    Lots, distribution and details
    Lots / codes
    Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156, 10163157, Exp. Date 08/10/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0664-2026
  • Class II Ongoing

    Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04

    Reason: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

    BioMed Laboratories, LLC.

    Lots, distribution and details
    Product
    Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
    Lots / codes
    Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027
    Distribution
    Nationwide in the US
    Quantity
    509,652 tubes
    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-0663-2026
  • Class II Ongoing

    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru – 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ…

    Reason: Failed Impurities/Degradation Specifications

    ONESOURCE SPECIALTY PHARMA LIMITED · Methohexital Sodium

    Lots, distribution and details
    Product
    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru – 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
    Lots / codes
    Lot #: 7000612A, Exp. Date 1/2028
    Distribution
    Nationwide within the United States
    Quantity
    4284 vials
    Recall started
    June 7, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0662-2026
  • Class II Ongoing

    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin L…

    Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

    Lupin Pharmaceuticals Inc. · Glucagon

    Lots, distribution and details
    Product
    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur – 441108, INDIA, NDC 70748-311-01
    Lots / codes
    Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.
    Distribution
    Nationwide within the U.S.
    Quantity
    64,894 units
    Recall started
    June 23, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0723-2026
  • Class II Ongoing

    Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hik…

    Reason: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

    McKesson · Gemcitabine

    Lots, distribution and details
    Product
    Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01
    Lots / codes
    Lot #: CB0046, Exp. Date 06/2027
    Distribution
    Nationwide within the United States
    Quantity
    74 units
    Recall started
    June 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0714-2026
  • Class II Ongoing

    Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01;…

    Reason: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

    Blaine Labs Inc

    Lots, distribution and details
    Product
    Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
    Lots / codes
    Lots: (a) 1 oz – BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
    Distribution
    Nationwide in the USA
    Quantity
    5,555 bottles and tubes
    Recall started
    April 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0699-2026
  • Class II Ongoing

    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1×2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1…

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

    Blaine Labs Inc

    Lots, distribution and details
    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1×2 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
    Lots / codes
    Lot BL3572, Exp 04/16/2028
    Distribution
    Nationwide in the USA
    Quantity
    1,500 bottles
    Recall started
    April 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0698-2026
  • Class II Ongoing

    TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

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

    Blaine Labs Inc

    Lots, distribution and details
    Lots / codes
    Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
    Distribution
    Nationwide in the USA
    Quantity
    5,801 bottles
    Recall started
    April 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0697-2026

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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