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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

    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.

    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
    Lot BL3462, Exp. 2/7/2027
    Distribution
    Nationwide in the USA
    Quantity
    26,475 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-0696-2026
  • Class II Ongoing

    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.

    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 BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
    Distribution
    Nationwide in the USA
    Quantity
    22,143 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-0695-2026
  • Class II Ongoing

    TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.

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

    Blaine Labs Inc

    Lots, distribution and details
    Product
    TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
    Lots / codes
    Lot #BL3411R, Exp 6/8/2027
    Distribution
    Nationwide in the USA
    Quantity
    144 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-0694-2026
  • Class II Ongoing

    TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.

    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
    Lots / codes
    Lot #: BL3435, Exp. 11/06/26
    Distribution
    Nationwide in the USA
    Quantity
    519 – 1 oz 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-0693-2026
  • Class I Ongoing

    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.

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

    Blaine Labs Inc

    Lots, distribution and details
    Lots / codes
    Lot#: BL3608, Exp. 07/01/28.
    Distribution
    Nationwide in the USA
    Quantity
    1,171 – 1 oz bottles
    Recall started
    April 8, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0692-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909…

    Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
    Lots / codes
    Lot #: 5PB0563, Exp 4/30/2027
    Distribution
    USA Nationwide
    Quantity
    N/A
    Recall started
    June 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0676-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909…

    Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02
    Lots / codes
    Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
    Distribution
    USA Nationwide
    Quantity
    N/A
    Recall started
    June 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0675-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909…

    Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02
    Lots / codes
    Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
    Distribution
    USA Nationwide
    Quantity
    31,824 bottles
    Recall started
    June 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0661-2026
  • Class II Ongoing

    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelph…

    Reason: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

    Lannett Company Inc. · Dextroamphetamine Sulfate

    Lots, distribution and details
    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.
    Lots / codes
    Lot#: 25285401A, Exp. Date: 04/2027
    Distribution
    US Nationwide.
    Quantity
    1392 bottles
    Recall started
    June 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0660-2026
  • Class II Ongoing

    Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.

    Reason: Lack of Assurance of Sterility

    Asclemed USA Inc. · Lidocaine Hydrochloride Anhydrous

    Lots, distribution and details
    Lots / codes
    Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
    Distribution
    USA Nationwide
    Quantity
    N/A
    Recall started
    June 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0659-2026
  • Class II Ongoing

    Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

    Reason: Lack of Assurance of Sterility

    Asclemed USA Inc. · Lidocaine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.
    Distribution
    USA Nationwide
    Quantity
    N/A
    Recall started
    June 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0658-2026
  • Class II Ongoing

    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA…

    Reason: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

    Boehringer Ingelheim Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
    Lots / codes
    Lot 3244413; Exp. 12/31/2028
    Distribution
    OH
    Quantity
    560 bottles
    Recall started
    June 12, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0657-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.
    Lots / codes
    Lot # D2401522, Exp Date: 06/2026.
    Distribution
    US Nationwide.
    Quantity
    6432 bottles
    Recall started
    June 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0656-2026
  • Class II Ongoing

    prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

    Reason: Presence of Foreign Substance

    Lupin Pharmaceuticals Inc. · Prednisolone Acetate

    Lots, distribution and details
    Lots / codes
    Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043, Expires: 12/31/2026; HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084, Expires: 1/31/2027; HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200, Expires: 2/28/2027; HB00224, HB00226, HB00228, HB00230, HB00240, HB00242, Expires: 3/31/2027; HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, HB00465, Expires: 5/31/2027; HB00561, Expires: 6/30/2027; HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, HB00679, Expires: 10/31/2027; HB00747, HB00749, HB00751, HB00753, Expires: 11/30/2027; HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, HC00028, Expires: 12/31/2027; HC00030, HC00032, Expires: 1/31/2028; HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, HC00083, Expires: 2/29/2028; HC00091, Expires: 3/31/2028; b) HA00945, HA00947, HA00949, Expires: 7/31/2026; HA01160, HA01162, HA01164, Expires: 10/31/2026; HA01234, HA01300, HA01302, Expires: 11/30/2026; HB00053, HB00055, HB00057, Expires: 1/31/2027; HB00107, HB00109, HB00111, HB00151, HB00153, HB00155, Expires: 2/28/2027; HB00386, HB00388, HB00390, HB00445, HB00447, Expires: 5/31/2027; HB00549, HB00551, HB00553, HB00555, Expires: 6/30/2027; HB00700, HB00702, Expires: 10/31/2027; HB00771, Expires: 11/30/2027; HC00008, HC00010, Expires: 12/31/2027; HC00034, HC00038, HC00054, HC00060, Expires: 1/31/2028; c) HA00951, HA00953, HA00955, Expires: 7/31/2026; HA01188, HA01190, HA01192, Expires: 10/31/2026; HA01304, Expires: 11/30/2026; HB00113, HB00115, Expires: 1/31/2027; HB00166, HB00168, Expires: 2/28/2027; HB00392, HB00394, HB00396, Expires:5/31/2027; HB00545, HB00547, Expires: 6/30/2027; HB00704, Expires: 10/31/2027; HB00773, Expires: 11/30/2027; HC00012, HC00014, Expires: 12/31/2027; HC00066, HC00068, Expires: 2/29/2028.
    Distribution
    U.S. Nationwide
    Quantity
    2,530,182 bottles
    Recall started
    June 4, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0655-2026
  • Class III Ongoing

    Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30

    Reason: Failed Impurities/Degradation Specifications

    SUN PHARMACEUTICAL INDUSTRIES INC · Fexofenadine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
    Distribution
    U.S. Nationwide
    Quantity
    9,048 bottles
    Recall started
    June 1, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0654-2026
  • Class II Ongoing

    IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Ind…

    Reason: Lack of assurance of Sterility:

    ACCORD BIOPHARMA INC · Ustekinumab

    Lots, distribution and details
    Product
    IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
    Lots / codes
    Lot # 004L24A, Exp Date: 02/19/2027.
    Distribution
    US Nationwide.
    Quantity
    326 vials
    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-0653-2026
  • Class II Ongoing

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 543…

    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 CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
    Lots / codes
    Lot: 4190081, Exp 06/30/2027
    Distribution
    Distributed Nationwide in the USA
    Quantity
    100 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-0652-2026
  • Class II Ongoing

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-…

    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 CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB
    Lots / codes
    Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    18,000 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-0651-2026
  • Class II Ongoing

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54…

    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 Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    125 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-0650-2026
  • Class II Ongoing

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case,…

    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 Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028
    Distribution
    Distributed Nationwide in the USA
    Quantity
    1,200 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-0649-2026
  • Class II Ongoing

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, b…

    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) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    400 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-0648-2026
  • Class II Ongoing

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catal…

    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) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    7,650 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-0647-2026
  • Class II Ongoing

    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC…

    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
    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
    Lots / codes
    Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    10,500 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-0646-2026
  • Class II Ongoing

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400…

    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 Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
    Lots / codes
    Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.
    Distribution
    Distributed Nationwide in the USA
    Quantity
    146,600 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-0645-2026
  • 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

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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