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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

    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
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), 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, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), 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 #: D2402186, Exp. Date 09/30/2026. b) Lot #: D2402019, Exp. Date 08/31/2026; D2402094, Exp. Date 09/30/2026; D2500022, D2500023, D2500021, 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-0779-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 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, 88 mcg (0.088 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 16729-450-17.
    Lots / codes
    Lot #: D2401813, D2401814, Exp. Date 08/31/2026; D2500200, D2500219, 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-0778-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 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, 75 mcg (0.075 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 16729-449-17.
    Lots / codes
    Lot #: D2402016, D2402017, Exp. Date 08/31/2026
    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-0777-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun…

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 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 16729-448-17.
    Lots / codes
    Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, 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-0776-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 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, 25 mcg (0.025 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 16729-447-17.
    Lots / codes
    Lot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026; D2500223, 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-0775-2026
  • Class II Ongoing

    Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

    Reason: Presence of Foreign Tablets/Capsules

    Bionpharma Inc. · Divalproex Sodium

    Lots, distribution and details
    Lots / codes
    Lot# 704C003, Exp. 12/31/2028
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    June 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0742-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal…

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
    Lots / codes
    Bag lot #: N02167A, Exp. Date 07/2026; Blister lot # N02167, Exp. Date 07/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0711-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal…

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
    Lots / codes
    Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0710-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
    Lots / codes
    Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0709-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
    Lots / codes
    Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0708-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
    Lots / codes
    Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0707-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
    Lots / codes
    Lot #: N02167, Exp. Date 07/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0706-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
    Lots / codes
    Lot #: N02266, Exp. Date 11/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0705-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
    Lots / codes
    Lot #: N02203, Exp. Date 09/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0704-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
    Lots / codes
    Lot #: N02310, Exp. Date 01/2027
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0703-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
    Lots / codes
    Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0702-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
    Lots / codes
    Lot #: N02200, Exp. Date 10/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0701-2026
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

    Reason: Subpotent Drug

    Major Pharmaceuticals · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
    Lots / codes
    Lot#: N02212, Exp. Date 07/2026
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    July 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0700-2026
  • Class II Ongoing

    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

    Reason: Failed Impurities/Degradation Specifications

    QuVa Pharma, Inc. · Methohexital Sodium

    Lots, distribution and details
    Lots / codes
    Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156, 10163157, Exp. Date 08/10/2026.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    June 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0664-2026
  • Class II Ongoing

    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru – 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ…

    Reason: Failed Impurities/Degradation Specifications

    ONESOURCE SPECIALTY PHARMA LIMITED · Methohexital Sodium

    Lots, distribution and details
    Product
    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru – 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
    Lots / codes
    Lot #: 7000612A, Exp. Date 1/2028
    Distribution
    Nationwide within the United States
    Quantity
    4284 vials
    Recall started
    June 7, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0662-2026
  • Class II Ongoing

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

    Reason: Subpotent Drug

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.
    Lots / codes
    Lot # D2401522, Exp Date: 06/2026.
    Distribution
    US Nationwide.
    Quantity
    6432 bottles
    Recall started
    June 8, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0656-2026
  • Class II Ongoing

    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

    Reason: Subpotent Drug

    IntegraDose Compounding Services LLC

    Lots, distribution and details
    Lots / codes
    Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026.
    Distribution
    U.S.A. Nationwide
    Quantity
    287 units
    Recall started
    May 18, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0593-2026
  • Class II Ongoing

    Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

    Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

    Hikma Pharmaceuticals USA INC · Alendronate Sodium

    Lots, distribution and details
    Lots / codes
    Lot # AC2040A, Exp Date: 04/2026
    Distribution
    US Nationwide.
    Quantity
    4 single dose 75 ml bottles
    Recall started
    April 7, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0526-2026

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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