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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.

183 recalls

  • Class II Ongoing

    Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Clindamycin Phosphate

    Lots, distribution and details
    Lots / codes
    Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0815-2026
  • Class II Ongoing

    Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430…

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Amiodarone Hydrochloride

    Lots, distribution and details
    Product
    Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
    Lots / codes
    Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0814-2026
  • Class II Ongoing

    CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA…

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Nicardipine Hydrochloride

    Lots, distribution and details
    Product
    CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
    Lots / codes
    Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0813-2026
  • Class II Ongoing

    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96…

    Reason: CGMP Deviations

    Baxter Healthcare Corporation

    Lots, distribution and details
    Product
    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
    Lots / codes
    Lot # NC194129, Exp Date: 05/07/2028.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0812-2026
  • Class II Ongoing

    Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Vasopressin

    Lots, distribution and details
    Lots / codes
    Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0811-2026
  • Class II Ongoing

    Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation

    Lots, distribution and details
    Lots / codes
    Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0810-2026
  • Class II Ongoing

    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-…

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Famotidine

    Lots, distribution and details
    Product
    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
    Lots / codes
    Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0809-2026
  • Class II Ongoing

    Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Clindamycin Phosphate

    Lots, distribution and details
    Lots / codes
    Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0808-2026
  • Class II Ongoing

    Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015…

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Daptomycin

    Lots, distribution and details
    Product
    Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.
    Lots / codes
    Lot # NC188692, Exp Date: 11/22/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0807-2026
  • Class II Ongoing

    MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Insulin Human

    Lots, distribution and details
    Lots / codes
    Lot # NC188630, NC188708, NC188791, NC188845, NC188876, NC188968, Exp Date: 12/31/2027; Lot # NC193719, NC193849, Exp Date: 04/30/2028; Lot # NC194051, NC194105, Exp Date: 05/31/2028; Lot # NC195171, Exp Date: 06/30/2028.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0806-2026
  • Class II Ongoing

    Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

    Reason: CGMP Deviations

    Baxter Healthcare Corporation · Vancomycin Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.
    Distribution
    US Nationwide; Puerto Rico; and Chile.
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0805-2026
  • Class I Ongoing

    Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00

    Reason: Presence of Particulate matter.

    B BRAUN MEDICAL INC

    Lots, distribution and details
    Lots / codes
    Lot#: J4H077, Exp 30NOV2026.
    Distribution
    U.S. Nationwide
    Quantity
    23,688 bags
    Recall started
    August 12, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0832-2026
  • Class II Ongoing

    Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by:…

    Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

    Hikma Pharmaceuticals USA INC. · Ramipril

    Lots, distribution and details
    Product
    Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
    Lots / codes
    a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
    Distribution
    Nationwide within the United States
    Quantity
    a) 25,970 bottles; b) 2,384 bottles
    Recall started
    August 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0831-2026
  • Class I Ongoing

    Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

    Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

    Fresenius Kabi USA, LLC · Tocilizumab

    Lots, distribution and details
    Product
    Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
    Lots / codes
    Lot: 16UI07, Exp 08/31/2028
    Distribution
    Nationwide in the USA
    Quantity
    4,643 20mL-vials
    Recall started
    August 10, 2026 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0827-2026
  • Class II Ongoing

    Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3

    Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

    Apotex Corp.

    Lots, distribution and details
    Lots / codes
    Lot # TY9494, Exp Date: 05/31/2027.
    Distribution
    US Nationwide.
    Quantity
    6,972 bottles
    Recall started
    August 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0804-2026
  • Class II Ongoing

    Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2

    Reason: Presence of particulate matter: glass and stopper piece

    Mallinckrodt Hospital Products Inc.

    Lots, distribution and details
    Lots / codes
    Lot#: NDC 63004-8710-1 – 1564-107, exp 1/31/2027 NDC 63004-8710-2 – 1564-107H, exp 1/31/2027
    Distribution
    USA Nationwide
    Quantity
    12367 vials
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0803-2026
  • Class II Ongoing

    Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.

    Reason: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

    Church & Dwight Co., Inc.

    Lots, distribution and details
    Lots / codes
    Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
    Distribution
    US Nationwide.
    Quantity
    318,600 cartons
    Recall started
    August 10, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0790-2026
  • Class II Ongoing

    Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.

    Reason: Failed content uniformity specifications.

    Lupin Pharmaceuticals Inc. · Clobetasol Propionate

    Lots, distribution and details
    Lots / codes
    Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
    Distribution
    USA Nationwide
    Quantity
    5082 tubes
    Recall started
    August 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0789-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
    Lots / codes
    Lot #: D2402337, Exp. Date 10/31/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0786-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
    Lots / codes
    a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0785-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
    Lots / codes
    a) Lot #: D2402642, Exp. Date 11/30/2026 b) Lot #: D2401832, Exp. Date 08/31/2026; D2402525, D2402527, D2402526, D2402644, D2402643, Exp. Date 11/30/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0784-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
    Lots / codes
    Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0783-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, M…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
    Lots / codes
    a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0782-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
    Lots / codes
    Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0781-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.
    Lots / codes
    Lot #: D2402443, D2402444, D2402445, Exp. Date 10/31/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    August 6, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0780-2026

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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