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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.

50 recalls

  • Class II Ongoing

    SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993…

    Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    Carolina Infusion, LLC

    Lots, distribution and details
    Product
    SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Lots / codes
    Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .
    Distribution
    Nationwide within the U.S
    Quantity
    82.9 mls – in patient specific syringe dose
    Recall started
    September 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0026-2027
  • Class II Ongoing

    SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993…

    Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    Carolina Infusion, LLC

    Lots, distribution and details
    Product
    SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Lots / codes
    Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    57.0 mls – in patient specific syringe doses
    Recall started
    September 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0019-2027
  • Class II Ongoing

    SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

    Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    Carolina Infusion, LLC · Semaglutide

    Lots, distribution and details
    Lots / codes
    Lot: 08262026@6, BUD:10/10/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    8 x 0.1 ml syringes
    Recall started
    September 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0018-2027
  • Class II Ongoing

    SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017275, Exp. 12/13/2026; AC-017282, AC-017285, Exp. 12/27/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    4,250 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0757-2026
  • Class II Ongoing

    SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017274, Exp. 12/12/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    500 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0756-2026
  • Class II Ongoing

    SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017273, Exp. 12/12/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    250 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0755-2026
  • Class II Ongoing

    SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017272, Exp. 12/12/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    250 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0754-2026
  • Class II Ongoing

    SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017271, Exp. 12/12/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    250 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0753-2026
  • Class II Ongoing

    SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017131, Exp. 8/30/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    4,748 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0752-2026
  • Class II Ongoing

    SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017125, Exp. 8/30/2026; AC-017138, AC-017147, AC-017214, AC-017226, AC-017228, Exp. 12/31/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    24,608 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0751-2026
  • Class II Ongoing

    SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017124, Exp. 8/30/2026; AC-017136, Exp. 12/31/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    9,762 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0750-2026
  • Class II Ongoing

    SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
    Distribution
    Nationwide within the U.S
    Quantity
    37,546 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0749-2026
  • Class II Ongoing

    SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
    Distribution
    Nationwide within the U.S
    Quantity
    23,029 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0748-2026
  • Class II Ongoing

    SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

    Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, AC-017225, Exp. 12/31/2026
    Distribution
    Nationwide within the U.S
    Quantity
    56,918 vials.
    Recall started
    July 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0747-2026
  • Class II Ongoing

    Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

    Reason: Lack of Assurance of Sterility

    PAYLESS COMPOUNDERS, LLC

    Lots, distribution and details
    Lots / codes
    Lot Number 01-27-2026@14S.5
    Distribution
    OR
    Quantity
    91 vials
    Recall started
    March 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0471-2026
  • Class II Ongoing

    Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

    Reason: Lack of Assurance of Sterility

    New Life Pharma LLC

    Lots, distribution and details
    Lots / codes
    Lot 240903, exp 9/30/2026
    Distribution
    OH
    Quantity
    2 vials
    Recall started
    February 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0393-2026
  • Class II Ongoing

    Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

    Reason: Lack of Assurance of Sterility

    New Life Pharma LLC

    Lots, distribution and details
    Lots / codes
    Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027
    Distribution
    OH
    Quantity
    820 vials
    Recall started
    February 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0392-2026
  • Class II Ongoing

    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer:…

    Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

    Harbin Jixianglong Biotech Co., Ltd. · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
    Lots / codes
    Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    February 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0380-2026
  • Class II Ongoing

    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotec…

    Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

    Harbin Jixianglong Biotech Co., Ltd. · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
    Lots / codes
    Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    February 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0379-2026
  • Class II Ongoing

    Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC…

    Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe

    Novo Nordisk Inc.

    Lots, distribution and details
    Product
    Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
    Lots / codes
    Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
    Distribution
    Nationwide within the United States.
    Quantity
    N/A
    Recall started
    December 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0245-2026
  • Class II Ongoing

    Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, N…

    Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe

    Novo Nordisk Inc.

    Lots, distribution and details
    Product
    Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
    Lots / codes
    Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026
    Distribution
    Nationwide within the United States.
    Quantity
    N/A
    Recall started
    December 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0244-2026
  • Class II Ongoing

    Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02

    Reason: Lack of Assurance of Sterility

    ProRx LLC · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
    Lots / codes
    Lot PRORX052125-4
    Distribution
    TX and UT
    Quantity
    2,805 vials
    Recall started
    October 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0119-2026
  • Class II Ongoing

    Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

    Reason: Lack of Assurance of Sterility

    ProRx LLC · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
    Lots / codes
    Lot Prorx051525-5
    Distribution
    TX and UT
    Quantity
    2,649 vials
    Recall started
    October 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0118-2026
  • Class II Ongoing

    Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

    Reason: Lack of Assurance of Sterility

    ProRx LLC · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Lots / codes
    Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
    Distribution
    TX and UT
    Quantity
    11,119 vials
    Recall started
    October 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0117-2026
  • Class II Ongoing

    Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08

    Reason: Lack of Assurance of Sterility

    ProRx LLC · Semaglutide

    Lots, distribution and details
    Product
    Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
    Lots / codes
    Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
    Distribution
    TX and UT
    Quantity
    8,310 vials
    Recall started
    October 15, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0116-2026

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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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