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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.

3 Class I (most serious) drug recalls reported in the last 30 days.

1,094 recalls

  • Class II Terminated

    LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01

    Reason: Lack of Sterility Assurance

    Regenerative Processing Plant, LLC

    Lots, distribution and details
    Lots / codes
    Lot #: P121322A, P121322B, Exp. Date 12/13/2024; P121422A, Exp. Date 12/14/2024; P121922A, P121922B, Exp. Date 12/19/2024; P122022A, Exp. Date 12/20/2024; P122122A, P122122B, Exp. Date 12/21/2024; P122622A, P122622B, Exp. Date 12/26/2024; P122722A, P122722B, Exp. Date 12/27/2024; P122822A, P122822B, Exp. Date 12/28/2024. P010223A, Exp. Date 1/2/2025; P010323LV1, Exp. Date 1/3/2025; P010523A, P010523B, Exp. Date 1/5/2025; P010923A, Exp. Date 1/9/2025; P011023LV2, Exp. Date 1/10/2025, P011223A, P011223B, Exp. Date 1/12/2025; P011623A; Exp. Date 1/16/2025, P011723LV3, Exp. Date 1/17/2025; P011923A, P011923B, Exp. Date 1/19/2025; P012323A, P012323B, Exp. Date 1/23/2025; P012523A, Exp. Date 1/25/2025; P013123A, Exp. Date 1/31/2025; P020223A, Exp. Date 2/2/2025; P020623A, Exp. Date 2/6/2025,P020823A, Exp. Date 2/8/2025, P020923A, Exp. Date 2/9/2025, P021323A, Exp. Date 2/13/2025; P021523A, P021523B, Exp. Date 2/15/2025, P021623A, Exp. Date 2/16/2025, P022023A, Exp. Date 2/20/2025, P022123A, Exp. Date 2/21/2025, P022323A, Exp. Date 2/23/2025, P022723A, Exp. Date 2/27/2025, P030123A, Exp. Date 3/1/2025, P030223A, Exp. Date 3/2/2025, P030623A, Exp. Date 3/6/2025; P030723A, Exp. Date 3/7/2025; P030823A, Exp. Date 3/8/2025; P030923A Exp. Date 3/9/2025, P031423A, Exp. Date 3/14/2025, P032023A, Exp. Date 3/20/2025, P032123A, Exp. Date 3/21/2025; P032223A, Exp. Date 3/22/2025; P032723A, Exp. Date 3/27/2025; P040423A, Exp. Date 4/4/2025; P040523A, Exp. Date 4/5/2025; P040623A, Exp. Date 4/6/2025; P041023A, Exp. Date 4/10/2025;P041123A, Exp. Date 4/11/2025; P041223A, Exp. Date 4/12/2025; P041323A, Exp. Date 4/13/2025; P041723A, Exp. Date 4/17/2025; P041823A, Exp. Date 4/18/2025;P041923A, Exp. Date 4/19/2025; P042023A, Exp. Date 4/20/2025; P042423A, Exp. Date 4/24/2025; P042523A, Exp. Date 4/25/2025;P042623A, Exp. Date 4/26/2025; P050323A, Exp. Date 5/3/2025; P050823A, Exp. Date 5/8/2025;P050923A, Exp. Date 5/9/2025;P051023A, Exp. Date 5/10/2025;P051123A, Exp. Date 5/11/2025;P051523A, Exp. Date 5/15/2025; P051623A, Exp. Date 5/16/2025; P051723A, Exp. Date 5/17/2025; P052223A, Exp.: 5/22/2025; P052323A, Exp.: 5/23/2025; P052423A, Exp. Date 5/24/2025; P052523A, Exp.: 5/25/2025; P053023A, Exp. Date 5/30/2025; P053123A, Exp. Date 5/31/2025; P060123A, Exp. Date 6/1/2025; P060223A, Exp. Date 6/2/2025; P060523A, Exp. Date 6/5/2025; P060623A, Exp. Date 6/6/2025; P060723A, Exp. Date 6/7/2025; P060823A, Exp. Date 6/8/2025; P061223A, Exp. Date 6/12/2025; P061323A, Exp. Date 6/13/2025; P061423A, Exp. Date 6/14/2025
    Distribution
    Nationwide within the United States
    Quantity
    170812 bottles
    Recall started
    December 10, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0152-2025
  • Class II Ongoing

    VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

    Reason: CGMP deviations: out of specifications for assay

    Apothecus Pharmaceutical Corp.

    Lots, distribution and details
    Lots / codes
    Lot: 3A001/3A001A, Exp: 07/25
    Distribution
    Nationwide in the USA and 2 Distributors in Hong Kong
    Quantity
    33,659 retail boxes in US
    Recall started
    November 22, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0151-2025
  • Class II Ongoing

    Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

    Reason: Discoloration

    Provepharm Inc. · Dihydroergotamine Mesylate

    Lots, distribution and details
    Lots / codes
    Lot #: F9026F01, F9026F02, Exp. Date 12/2025
    Distribution
    Nationwide within the United States
    Quantity
    2160 packs/5 ampules per pack = 10,800 ampules
    Recall started
    November 22, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0150-2025
  • Class II Ongoing

    Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

    Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

    Aurobindo Pharma USA Inc · Nebivolol

    Lots, distribution and details
    Product
    Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
    Lots / codes
    Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    December 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0149-2025
  • Class II Terminated

    Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,

    Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

    Keystone Industries

    Lots, distribution and details
    Lots / codes
    Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
    Distribution
    Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
    Quantity
    —
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0148-2025
  • Class II Terminated

    safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professi…

    Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

    Keystone Industries · Benzocaine

    Lots, distribution and details
    Product
    safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
    Lots / codes
    Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
    Distribution
    Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
    Quantity
    —
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0145-2025
  • Class II Ongoing

    Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

    Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

    Ascend Laboratories, LLC · Dabigatran Etexilate

    Lots, distribution and details
    Lots / codes
    Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
    Distribution
    Nationwide within the United States
    Quantity
    10,444 bottles
    Recall started
    December 12, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0130-2025
  • Class II Ongoing

    Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

    Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

    Ascend Laboratories, LLC · Dabigatran Etexilate

    Lots, distribution and details
    Lots / codes
    Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
    Distribution
    Nationwide within the United States
    Quantity
    1971 bottles
    Recall started
    December 12, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0129-2025
  • Class III Ongoing

    Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

    Reason: Failed Impurities/Degradation Specifications

    Dr. Reddy's Laboratories, Inc. · Sapropterin Dihydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.
    Distribution
    U.S. Nationwide
    Quantity
    7,233 bottles
    Recall started
    November 22, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0117-2025
  • Class II Terminated

    Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4×1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares…

    Reason: cGMP Deviations: Temperature excursion

    Mckesson Medical-Surgical Inc. Corporate Office · Hyaluronidase

    Lots, distribution and details
    Product
    Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4×1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
    Lots / codes
    Serial # 100000831961 100000820688 100000820689 100000820515
    Distribution
    Virgina
    Quantity
    5 cartons/20 units each carton
    Recall started
    September 11, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0116-2025
  • Class II Ongoing

    Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-1…

    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.

    FDC Limited · Timolol Maleate

    Lots, distribution and details
    Product
    Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
    Lots / codes
    Lot #: 083I006, Exp 08/31/2025
    Distribution
    Distributed to one Us Distributor in NJ.
    Quantity
    5184 bottles
    Recall started
    December 5, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0114-2025
  • Class III Terminated

    Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG Inter…

    Reason: Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

    Biocompatibles UK, Ltd.

    Lots, distribution and details
    Product
    Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
    Lots / codes
    Lot # 34067418, Exp. March 2026, 34067419, Exp. March 2026
    Distribution
    Nationwide in the USA.
    Quantity
    432 administration packs
    Recall started
    August 15, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0113-2025
  • Class II Terminated

    Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

    Reason: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

    Lannett Company Inc. · Lisdexamfetamine Dimesylate

    Lots, distribution and details
    Product
    Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
    Lots / codes
    Lot: 23274856A, Exp 04/30/2025
    Distribution
    Nationwide in the USA
    Quantity
    1608 bottles
    Recall started
    October 25, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0112-2025
  • Class II Ongoing

    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25
    Distribution
    Nationwide.
    Quantity
    233,003 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0107-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Bru…

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Lots / codes
    a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25
    Distribution
    Nationwide.
    Quantity
    122,925 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0106-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Lots / codes
    a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
    Distribution
    Nationwide.
    Quantity
    209,376 bottles
    Recall started
    November 19, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0105-2025
  • Class III Ongoing

    Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…

    Reason: Labeling: Not Elsewhere Classified – Wrong NDC number

    Zydus Pharmaceuticals (USA) Inc · Esomeprazole Magnesium

    Lots, distribution and details
    Product
    Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
    Lots / codes
    Lot#: M408002, Exp 05/31/2026
    Distribution
    USA Nationwide.
    Quantity
    4404 packs
    Recall started
    November 14, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0102-2025
  • Class II Ongoing

    Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509

    Reason: cGMP Deviations: Out of specification results for micro in hand soap products.

    Midlab Incorporated

    Lots, distribution and details
    Lots / codes
    Lot 0711241
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    November 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0089-2025
  • Class I Ongoing

    ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

    Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

    Boulla LLC

    Lots, distribution and details
    Lots / codes
    Lot #: YZM240406, Exp: 04/05/2027
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    November 4, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0086-2025
  • Class I Ongoing

    ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

    Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

    Boulla LLC

    Lots, distribution and details
    Lots / codes
    Lot #: YZM240406, Exp: 04/05/2027
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    November 4, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0085-2025
  • Class I Ongoing

    PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

    Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

    Boulla LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 230811, Exp: 08/11/2025
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    November 4, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0084-2025
  • Class I Ongoing

    VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com

    Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

    Boulla LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 230811, Exp: 08/11/2025
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    November 4, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0083-2025
  • Class II Ongoing

    Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-…

    Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.

    American Regent, Inc. · Iron Sucrose

    Lots, distribution and details
    Product
    Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
    Lots / codes
    Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    November 11, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0081-2025
  • Class II Ongoing

    Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01…

    Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.

    American Regent, Inc. · Iron Sucrose

    Lots, distribution and details
    Product
    Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
    Lots / codes
    Lot#s: 4196, Exp 05/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    —
    Recall started
    November 11, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0080-2025
  • Class II Ongoing

    Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Win…

    Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    Aurobindo Pharma USA Inc · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg – 30 Tablets – NDC 65862-833-30 90 mg – 500 Tablets – NDC 65862-833-05
    Lots / codes
    Lot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024
    Distribution
    USA Nationwide
    Quantity
    —
    Recall started
    November 7, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0079-2025

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 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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