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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.

3,222 recalls

  • Class II Ongoing

    Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for…

    Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Amerisource Health Services LLC · Haloperidol Decanoate

    Lots, distribution and details
    Product
    Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
    Lots / codes
    A240482B, EXP 08/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    143 1×5 vials
    Recall started
    April 2, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0369-2025
  • Class II Ongoing

    Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore – 562123, Karnataka, India, Manufactured f…

    Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Amerisource Health Services LLC · Haloperidol Decanoate

    Lots, distribution and details
    Product
    Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore – 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
    Lots / codes
    A240482A, EXP 08/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    14,189 vials
    Recall started
    April 2, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0368-2025
  • Class II Ongoing

    Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore – 562123, Karnataka, India, Manufactured for: Blu…

    Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Amerisource Health Services LLC · Haloperidol Decanoate

    Lots, distribution and details
    Product
    Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore – 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
    Lots / codes
    A240467B, EXP 07/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    2,110 vials
    Recall started
    April 2, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0367-2025
  • 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

    Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

    Reason: CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

    Chattem Inc

    Lots, distribution and details
    Lots / codes
    LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
    Distribution
    Nationwide.
    Quantity
    129,240 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-0362-2025
  • 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

    Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

    Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

    Somerset Therapeutics Private Limited · Haloperidol Decanoate

    Lots, distribution and details
    Lots / codes
    A240482D, exp. date 08/2026
    Distribution
    U.S. Nationwide
    Quantity
    240 vials
    Recall started
    March 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0358-2025
  • Class II Ongoing

    Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and…

    Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

    Somerset Therapeutics Private Limited · Haloperidol Decanoate

    Lots, distribution and details
    Product
    Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5×1 mL cartons)
    Lots / codes
    NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
    Distribution
    U.S. Nationwide
    Quantity
    23,960 vials
    Recall started
    March 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0357-2025
  • Class II Ongoing

    Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

    Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

    Somerset Therapeutics Private Limited · Haloperidol Decanoate

    Lots, distribution and details
    Lots / codes
    A240467B, exp. date 07/2026
    Distribution
    U.S. Nationwide
    Quantity
    4956 vials
    Recall started
    March 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0356-2025
  • Class II Ongoing

    Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10×1 mL carton)

    Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

    Somerset Therapeutics Private Limited · Haloperidol Decanoate

    Lots, distribution and details
    Lots / codes
    NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
    Distribution
    U.S. Nationwide
    Quantity
    997 vials
    Recall started
    March 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0355-2025
  • Class II Ongoing

    Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5×10 mL car…

    Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination

    Somerset Therapeutics Private Limited · Methocarbamol

    Lots, distribution and details
    Product
    Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5×10 mL carton)
    Lots / codes
    NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347, A240385, A240391, exp. date 06/2026; NDC 70069-101-05; A240326, exp. date 05/2026
    Distribution
    U.S. Nationwide
    Quantity
    506,080 vials
    Recall started
    March 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0354-2025
  • Class II Ongoing

    0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

    Reason: Presence of Particulate Matter

    B. Braun Medical Inc · Sodium Acetate Anhydrous

    Lots, distribution and details
    Lots / codes
    Lot # J4K936, Exp 7/31/2027
    Distribution
    Product was distributed to 12 distributors who may have further distributed the product nationwide.
    Quantity
    32,256 Bottles
    Recall started
    March 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0353-2025
  • Class II Ongoing

    Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. N…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Propafenone Hydrochloride

    Lots, distribution and details
    Product
    Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01
    Lots / codes
    Lot # 17230767, exp. date Mar-25
    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-0352-2025
  • Class II Ongoing

    Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Propafenone Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # 17230819, exp. date Mar-25
    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-0351-2025
  • Class II Ongoing

    Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampu…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Pravastatin Sodium

    Lots, distribution and details
    Product
    Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
    Lots / codes
    Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-26
    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-0350-2025
  • Class II Ongoing

    Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Pravastatin Sodium

    Lots, distribution and details
    Lots / codes
    Lot # 17230810, exp. date Mar-26
    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-0349-2025
  • 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 II Ongoing

    Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Naproxen Sodium

    Lots, distribution and details
    Product
    Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
    Lots / codes
    Lot # 17231956, exp. date Aug-25
    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-0346-2025
  • Class II Ongoing

    Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured fo…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Saxagliptin

    Lots, distribution and details
    Product
    Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
    Lots / codes
    30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 26
    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-0345-2025

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 2, 2026 14:41. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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