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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.

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

1,094 recalls

  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge P…

    Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
    Lots / codes
    Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
    Distribution
    US Nationwide.
    Quantity
    343,344 bottles
    Recall started
    April 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0388-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-1…

    Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    Breckenridge Pharmaceutical, Inc · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
    Lots / codes
    Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
    Distribution
    US Nationwide.
    Quantity
    16,473 bottles
    Recall started
    April 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0387-2025
  • Class II Terminated

    Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30

    Reason: cGMP deviations

    Pharmadel, LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: UDE-01, EXP: OCT 26
    Distribution
    DE
    Quantity
    10,752 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0384-2025
  • Class II Terminated

    Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99

    Reason: cGMP deviations

    Pharmadel, LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: EAT-01, EXP: MAR 27
    Distribution
    DE
    Quantity
    6,048 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0383-2025
  • Class II Terminated

    Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

    Reason: cGMP deviations

    Pharmadel, LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: EAG-01, EXP: MAR 27
    Distribution
    DE
    Quantity
    6,048 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0382-2025
  • Class II Terminated

    Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

    Reason: cGMP deviations

    Pharmadel, LLC · Salicylic Acid

    Lots, distribution and details
    Lots / codes
    Lot, expiry: KSE-01, EXP: OCT 26; KSE-02, EXP: FEB 27
    Distribution
    DE
    Quantity
    20,048 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0381-2025
  • Class II Terminated

    DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

    Reason: cGMP deviations

    Pharmadel, LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: DEE-01, EXP: OCT 26; DEE-02 EXP: FEB 27
    Distribution
    DE
    Quantity
    27,648 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0380-2025
  • Class II Terminated

    DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

    Reason: cGMP deviations

    Pharmadel, LLC

    Lots, distribution and details
    Lots / codes
    Lot EDD-01
    Distribution
    DE
    Quantity
    9504 bottles
    Recall started
    April 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0379-2025
  • Class II Ongoing

    Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe…

    Reason: CGMP Deviations

    Apipharma

    Lots, distribution and details
    Product
    Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
    Lots / codes
    Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
    Distribution
    AZ
    Quantity
    5,095 cartons
    Recall started
    April 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0376-2025
  • Class II Ongoing

    Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318

    Reason: CGMP Deviations

    Apipharma

    Lots, distribution and details
    Product
    Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
    Lots / codes
    Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02
    Distribution
    AZ
    Quantity
    4,218 boxes
    Recall started
    April 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0375-2025
  • Class II Ongoing

    ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10×10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

    Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

    The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Chlorpromazine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot#: N02114, Exp 12/31/2025
    Distribution
    Nationwide USA
    Quantity
    133 cartons
    Recall started
    April 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0366-2025
  • Class I Ongoing

    Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, – 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, N…

    Reason: LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

    Dr. Reddy's Laboratories, Inc. · Levetiracetam

    Lots, distribution and details
    Product
    Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, – 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
    Lots / codes
    Lot: A1540076, Exp 08/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    4,010 bags
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0365-2025
  • Class II Ongoing

    CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

    Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    Direct Rx

    Lots, distribution and details
    Lots / codes
    Lot 11SE2402, Exp Date: 11/30/2025 Lot 14NO2406, Exp Date: 12/31/2025 Lot 29OC2420, Exp Date: 11/30/2025 Lot 30SE2412, Exp Date: 11/30/2025
    Distribution
    Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
    Quantity
    477 bottles.
    Recall started
    January 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0364-2025
  • Class II Ongoing

    Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01

    Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

    Eugia US LLC · Testosterone Cypionate

    Lots, distribution and details
    Product
    Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
    Lots / codes
    Lot #: 1TC24075A, Exp 11/30/2026.
    Distribution
    Nationwide USA
    Quantity
    36,816 vials
    Recall started
    April 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0363-2025
  • Class II Ongoing

    chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-112…

    Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

    Zydus Pharmaceuticals (USA) Inc · Chlorpromazine Hydrochloride

    Lots, distribution and details
    Product
    chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
    Lots / codes
    Lot #: Z400069, Exp.: 12/31/2025
    Distribution
    Nationwide within U.S – MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
    Quantity
    3144 bottles, pack size: 100's Count
    Recall started
    April 3, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0361-2025
  • Class II Ongoing

    Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,

    Reason: Chemical contamination: Presence of benzene

    Alchemee, LLC

    Lots, distribution and details
    Lots / codes
    Lot, V4204A, Exp 07/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    3,500 bottles
    Recall started
    March 12, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0360-2025
  • Class II Ongoing

    Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack…

    Reason: Chemical contamination: Presence of benzene

    Alchemee, LLC

    Lots, distribution and details
    Product
    Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,
    Lots / codes
    Lots V3304A, V3305A, Exp 10/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    38,237 bottles
    Recall started
    March 12, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0359-2025
  • Class II Ongoing

    Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Cetirizine

    Lots, distribution and details
    Lots / codes
    Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0348-2025
  • Class II Ongoing

    Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of Ind…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA

    Lots, distribution and details
    Product
    Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
    Lots / codes
    Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0347-2025
  • Class III Ongoing

    Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured…

    Reason: Cross Contamination

    SUN PHARMACEUTICAL INDUSTRIES INC · Gabapentin

    Lots, distribution and details
    Product
    Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
    Lots / codes
    Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
    Distribution
    Nationwide in the USA
    Quantity
    852 bottles
    Recall started
    March 4, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0312-2025
  • Class III Ongoing

    Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured…

    Reason: Cross Contamination

    SUN PHARMACEUTICAL INDUSTRIES INC · Gabapentin

    Lots, distribution and details
    Product
    Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
    Lots / codes
    Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
    Distribution
    Nationwide in the USA
    Quantity
    12,876 bottles
    Recall started
    March 4, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0311-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc.,…

    Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

    Breckenridge Pharmaceutical, Inc. · Duloxetine Hydrochloride

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
    Lots / codes
    Lot 240909C, Exp Date 03/31/2027
    Distribution
    Nationwide in the US
    Quantity
    14,863 bottles
    Recall started
    March 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0308-2025
  • Class II Terminated

    Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687…

    Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

    Amerisource Health Services LLC · Voriconazole

    Lots, distribution and details
    Product
    Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
    Lots / codes
    Lot # 1014138, Exp 04/30/2025
    Distribution
    USA nationwide.
    Quantity
    889 cartons
    Recall started
    March 24, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0307-2025
  • Class III Terminated

    Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

    Reason: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

    The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Tolterodine Tartrate

    Lots, distribution and details
    Lots / codes
    Lot# T05393, Exp. Date: 09/30/2025
    Distribution
    Nationwide in the USA
    Quantity
    224 cartons
    Recall started
    March 4, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0304-2025
  • Class I Ongoing

    SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distribu…

    Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

    Ascent Consumer Products Inc.

    Lots, distribution and details
    Product
    SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
    Lots / codes
    Lot# 024122661Al, Exp Date 12/2027
    Distribution
    Nationwide in the US.
    Quantity
    unknown
    Recall started
    January 28, 2025 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0301-2025

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 November 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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