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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.

311 recalls

  • Class II Ongoing

    Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

    Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

    Akorn, Inc. · Cromolyn Sodium

    Lots, distribution and details
    Product
    Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Lots / codes
    All Lots
    Distribution
    Nationwide in the USA and Puerto Rico
    Quantity
    N/A
    Recall started
    April 26, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0797-2023
  • Class II Ongoing

    HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

    Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

    SSM Health Care St. Louis DBA SSM St. Clare Health Center

    Lots, distribution and details
    Product
    HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
    Lots / codes
    Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023
    Distribution
    Product was distributed in Missouri.
    Quantity
    3,232 syringes
    Recall started
    May 9, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0776-2023
  • Class II Ongoing

    VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023
    Distribution
    Missouri only
    Quantity
    646 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0647-2023
  • Class II Ongoing

    FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023
    Distribution
    Missouri only
    Quantity
    308 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0646-2023
  • Class II Ongoing

    VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016632, Exp. Date 05/24/2023
    Distribution
    Missouri only
    Quantity
    491 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0645-2023
  • Class II Ongoing

    VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016649, Exp. Date 07/01/2023
    Distribution
    Missouri only
    Quantity
    54 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0643-2023
  • Class II Ongoing

    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Product
    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
    Lots / codes
    Lot #: AC-016638, Exp. Date 05/27/2023
    Distribution
    Missouri only
    Quantity
    413 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0642-2023
  • Class II Ongoing

    VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016648, Exp. Date 07/01/2023
    Distribution
    Missouri only
    Quantity
    240 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0641-2023
  • Class II Ongoing

    VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016641, Exp. Date 06/03/2023; AC-016653 Exp. Date 07/26/2023
    Distribution
    Missouri only
    Quantity
    1622 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0640-2023
  • Class II Ongoing

    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016647, Exp. Date 06/28/2023
    Distribution
    Missouri only
    Quantity
    1113 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0639-2023
  • Class II Ongoing

    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016647, Exp. Date 06/28/2023
    Distribution
    Missouri only
    Quantity
    1113 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0638-2023
  • Class II Ongoing

    Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot#: AC-016631, Exp. Date 05/29/2023; AC-016655, Exp. Date 08/07/2023
    Distribution
    Missouri only
    Quantity
    1617 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0637-2023
  • Class II Ongoing

    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

    Reason: Lack of Assurance of Sterility

    Apollo Care, LLC

    Lots, distribution and details
    Lots / codes
    Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023
    Distribution
    Missouri only
    Quantity
    2040 bags
    Recall started
    May 2, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0636-2023
  • Class II Ongoing

    Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar…

    Reason: CGMP Deviations: Discoloration

    Hetero USA Inc · Pantoprazole

    Lots, distribution and details
    Product
    Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
    Lots / codes
    Lot #: PAN22542, Exp. Date: 9/2024
    Distribution
    Nationwide within the United States
    Quantity
    2,352 bottles
    Recall started
    March 14, 2023 (N/A)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0530-2023
  • Class II Ongoing

    Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Pravastatin Sodium

    Lots, distribution and details
    Lots / codes
    Lot: F1021I; H3122J, Exp 4/30/2024
    Distribution
    USA Nationwide
    Quantity
    24 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0521-2023
  • Class II Ongoing

    Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Du…

    Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Preferred Pharmaceuticals, Inc. · Montelukast Sodium

    Lots, distribution and details
    Product
    Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
    Lots / codes
    a) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.
    Distribution
    USA Nationwide
    Quantity
    a) 266 Bottles, b) not reported, c) 216 Bottles
    Recall started
    March 23, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0518-2023
  • Class II Ongoing

    Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

    Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

    Apollo Care

    Lots, distribution and details
    Lots / codes
    Lot #: AC-016581
    Distribution
    MO
    Quantity
    215 bags
    Recall started
    February 8, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0487-2023
  • Class II Ongoing

    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

    Reason: CGMP Deviations:

    Akorn, Inc. · Sodium Acetate Anhydrous

    Lots, distribution and details
    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
    Lots / codes
    Lot: 0F69A, EXP 5/31/2023; 0G92B, 0G92A, EXP 6/30/2023; 0J69A, EXP 8/31/2023; 0K29A, 0K24A, EXP 9/30/2023; 0M93A, 0M92A, 0M92B, EXP 11/30/2023; 1B25A, EXP 1/31/2024; 1C74A, EXP 2/29/2024; 1E19A, EXP 4/30/2024; 1C77A, EXP 2/29/2024;
    Distribution
    Nationwide in the USA
    Quantity
    524,506 tubes
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0155-2023
  • Class II Ongoing

    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

    Reason: CGMP Deviations:

    Akorn, Inc. · Cromolyn Sodium

    Lots, distribution and details
    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    Lots / codes
    Lot: 0G75A, 0G12A, EXP 6/30/2023; 0H50A, EXP 7/31/2023; 0J88A, EXP 8/31/2023; 1D98A, EXP 3/31/2024; 1E31A, EXP 4/30/2024; 1D97A, EXP 3/31/2024; 1H14A, EXP 7/31/2024;
    Distribution
    Nationwide in the USA
    Quantity
    188,550 bottles
    Recall started
    October 13, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0137-2023
  • Class II Ongoing

    Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

    Reason: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

    Eugia US LLC · Acyclovir Sodium

    Lots, distribution and details
    Product
    Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
    Lots / codes
    Lot # AC22004, Expiry: 08/2023
    Distribution
    Nationwide in the USA
    Quantity
    45,250 vials
    Recall started
    December 28, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0095-2023
  • Class II Ongoing

    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP – 900 mg, WATER FOR INJECTION, USP – qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-…

    Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

    Fresenius Medical Care Holdings, Inc. · Sodium Acetate Anhydrous

    Lots, distribution and details
    Product
    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP – 900 mg, WATER FOR INJECTION, USP – qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
    Lots / codes
    Lot # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
    Distribution
    Product was distributed Nationwide in the USA.
    Quantity
    4,097 cases/12 bags per case
    Recall started
    November 22, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0075-2023
  • Class II Ongoing

    0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

    Reason: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

    ICU Medical Inc · Sodium Acetate Anhydrous

    Lots, distribution and details
    Lots / codes
    Lot: 5829936, Exp. MAR 31 2024
    Distribution
    Nationwide in the USA
    Quantity
    137,120 bags
    Recall started
    November 9, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0062-2023
  • Class II Ongoing

    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP – 900 mg, WATER FOR INJECTION, USP – qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-…

    Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

    Fresenius Medical Care Holdings, Inc. · Sodium Acetate Anhydrous

    Lots, distribution and details
    Product
    0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP – 900 mg, WATER FOR INJECTION, USP – qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
    Lots / codes
    Lot # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023
    Distribution
    Nationwide in the USA
    Quantity
    16,006 cases of twelve bags each
    Recall started
    October 11, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0015-2023
  • Class II Ongoing

    Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Pentosan Polysulfate Sodium

    Lots, distribution and details
    Product
    Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    220 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1221-2022
  • Class II Ongoing

    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

    Reason: Defective container: Out of specification for container integrity leading to bottles leaking.

    Preferred Pharmaceuticals, Inc. · Diclofenac Sodium

    Lots, distribution and details
    Lots / codes
    Lot #: E1220B
    Distribution
    Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
    Quantity
    72 bottles
    Recall started
    November 29, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0278-2022

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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