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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.

3,250 recalls

  • Class I Terminated

    Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak…

    Reason: Chemical contamination: Presence of benzene

    Blistex Inc · Tolnaftate

    Lots, distribution and details
    Product
    Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
    Lots / codes
    a) Lot #: D19K22, D19K23, Exp. Date 10/21; D19M24, D19M25, D19M26, D19M27, Exp. Date 12/21; D20C01, D20C02, D20C03, D20C04, Exp. Date 3/22; D20F08, D20F09, Exp. Date 6/22; LD20H10, D20H11, Exp. Date 8/22; D20K13, D20K14, Exp. Date 10/22 D21B01, Exp. Date 2/23; D21D03, Exp. Date 4/23; D21E04, D21F04, Exp. Date 5/23; D21F05, Exp. Date 6/23; D21G01, D21G02, Exp. Date 7/23; D21H03, D21H04, D21H05, Exp. Date 8/23. b) Lot #: D19M27, D19M28, D19M29, D19M30, Exp. Date 12/21; D20E05, D20E06, D20E07, Exp. Date 5/22; D20M15, D20M16, Exp. Date 12/22; D21B02, Exp. Date 2/23
    Distribution
    Nationwide with the USA, Canada and Korea
    Quantity
    243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
    Recall started
    November 17, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0159-2024
  • Class I Ongoing

    THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7

    Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

    Noah's Wholesale LLC

    Lots, distribution and details
    Lots / codes
    Lot# 03032021 Exp: 12/31/2027
    Distribution
    Florida, Bahamas, Turks & Caicos Islands
    Quantity
    173 capsules
    Recall started
    October 16, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0158-2024
  • Class II Ongoing

    NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5

    Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

    Fagron, Inc

    Lots, distribution and details
    Product
    NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
    Lots / codes
    Lot #: 221031-U42104, Exp. date 04/30/2025
    Distribution
    Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
    Quantity
    52 containers
    Recall started
    December 11, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0157-2024
  • Class II Ongoing

    NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6

    Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

    Fagron, Inc

    Lots, distribution and details
    Product
    NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
    Lots / codes
    Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025
    Distribution
    Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
    Quantity
    9 containers
    Recall started
    December 11, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0156-2024
  • Class II Ongoing

    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9

    Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

    Fagron, Inc

    Lots, distribution and details
    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Lots / codes
    Lot #: 230308-U46225, Exp. date 04/30/2025, 221031-U42110, Exp. date 04/30/2025
    Distribution
    Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
    Quantity
    46 containers
    Recall started
    December 11, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0155-2024
  • Class II Ongoing

    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3

    Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

    Fagron, Inc

    Lots, distribution and details
    Product
    NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. – 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
    Lots / codes
    Lot#: 230308-U46196, Exp. date 04/30/2025
    Distribution
    Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
    Quantity
    13 containers
    Recall started
    December 11, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0154-2024
  • Class I Terminated

    Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

    Reason: Failed Content Uniformity Specifications

    The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Phenytoin

    Lots, distribution and details
    Lots / codes
    Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
    Distribution
    Nationwide in the USA
    Quantity
    3718 saleable units
    Recall started
    October 23, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0153-2024
  • Class II Ongoing

    Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.

    Reason: CGMP Deviations: Stability data does not support expiry date.

    Private Label Partners, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #220551, Exp: 2/28/2025
    Distribution
    NJ
    Quantity
    3,396 bottles
    Recall started
    December 13, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0152-2024
  • Class I Completed

    TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532…

    Reason: Chemical Contamination; presence of benzene.

    Insight Pharmaceuticals Corporation

    Lots, distribution and details
    Product
    TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
    Lots / codes
    Lot #s: 0H88645, Exp 07/31/2024; 0B88345, Exp 02/29/2024.
    Distribution
    Nationwide and Puerto Rico
    Quantity
    117,336 cans
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0151-2024
  • Class II Terminated

    Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 1…

    Reason: Failed Impurities/Degradation Specifications

    SUN PHARMACEUTICAL INDUSTRIES INC · Liothyronine Sodium

    Lots, distribution and details
    Product
    Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
    Lots / codes
    Lot DND0059A Expires 12/2023 Lot DND0060A Expires 12/2023 Lot DND0061A Expires 12/2023 Lot DND0062A Expires 01/2024 Lot DND0063A Expires 01/2024 Lot DND0064A Expires 01/2024 Lot DND0065A Expires 01/2024 Lot DND0180A Expires 01/2024 Lot DND0181A Expires 01/2024 Lot DND0182A Expires 01/2024 Lot DND0183A Expires 01/2024 Lot DND0184A Expires 01/2024 Lot DND0597A Expires 02/2024
    Distribution
    Nationwide
    Quantity
    96,192 bottles
    Recall started
    December 4, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0150-2024
  • Class III Completed

    Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-…

    Reason: Failed Dissolution Specifications

    Siegfried Barbera, SL · Pazopanib Hydrochloride

    Lots, distribution and details
    Product
    Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
    Lots / codes
    Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
    Distribution
    Nationwide
    Quantity
    2016
    Recall started
    November 20, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0149-2024
  • Class II Terminated

    Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

    Reason: Failed Dissolution Specifications

    Lupin Pharmaceuticals Inc. · Penicillamine

    Lots, distribution and details
    Lots / codes
    Lot # M200498, Exp. June 2024
    Distribution
    Product was distributed to 3 wholesale/distributor accounts.
    Quantity
    N/A
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0148-2024
  • Class II Completed

    ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,

    Reason: STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

    STAQ Pharma, Inc.

    Lots, distribution and details
    Lots / codes
    Lot#: 23109472A, Exp. date 03/10/2024; 23109473A, Exp. date 03/11/2024; 23109474A, Exp. date 03/13/2024; 23109491A, Exp. date 03/16/2024; 23109492A, Exp. date 03/19/2024; 23109501A, Exp. date 03/25/2024; 23109520A, Exp. date 04/10/2024; 23109521A, Exp. date 04/13/2024; 23109522A, Exp. date 04/03/2024.
    Distribution
    Nationwide within the United States
    Quantity
    2616 bags
    Recall started
    November 29, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0147-2024
  • Class II Completed

    Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 3822…

    Reason: Failed pH Specifications

    Baxter Healthcare Corporation · Ondansetron Hydrochloride

    Lots, distribution and details
    Product
    Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25
    Lots / codes
    Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24; A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24; A0F0596A, A0F0599A, Exp. Date 31-Aug-24 ; A0F0676A, 31-Oct-24.
    Distribution
    Nationwide in the USA
    Quantity
    6,022,675 vials
    Recall started
    November 14, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0146-2024
  • Class I Ongoing

    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover…

    Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

    Novartis Pharmaceuticals Corporation

    Lots, distribution and details
    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
    Lots / codes
    Lot #: FX001500, FX001582, Exp. 09/30/2024
    Distribution
    Nationwide within the United States
    Quantity
    6,997 bottles
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0144-2024
  • Class II Ongoing

    KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.

    Reason: Failed Impurities/Degradation Specifications

    KINDER FARMS LLC

    Lots, distribution and details
    Lots / codes
    Lot #: CJ70902, Exp: 07/2024; CJ76275, WJ81412, Exp: 08/2024; WK02194, WK02196, WK04141, WK02873, WK05542, Exp: 10/2024; WK02874, WK04794, Exp: 01/2025; WK04793, WK06535, Exp: 03/2025.
    Distribution
    Nationwide
    Quantity
    376,370 bottles
    Recall started
    November 13, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0143-2024
  • Class II Ongoing

    KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.

    Reason: Failed Impurities/Degradation Specifications

    KINDER FARMS LLC

    Lots, distribution and details
    Lots / codes
    Lot: CJ70900, CJ76796, Exp: 8/2024; CJ77051, Exp: 09/2024; WK02998, WK02997, WK04390, WK02999, Exp: 10/2024; WK03716, Exp:12/2024; WK05150, WK05151, WK07174, Exp:02/2025; WK05539, WK06534, Exp: 03/2025; WK10259, WK23040, Exp: 04/2025; WK27455, Exp: 08/2025.
    Distribution
    Nationwide
    Quantity
    591,684 bottles
    Recall started
    November 13, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0142-2024
  • Class II Completed

    ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

    Reason: Lack of assurance of sterility.

    Wells Pharma of Houston LLC

    Lots, distribution and details
    Lots / codes
    Lot # 11092313110#01, Exp 01/12/24
    Distribution
    Philadelphia, Pennsylvania.
    Quantity
    825 syringes
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0141-2024
  • Class III Terminated

    LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063…

    Reason: Product Mix-up: Incorrect Product Formulation

    Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop

    Lots, distribution and details
    Product
    LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
    Lots / codes
    Lot#: 09202023@7, Exp 03/18/2024
    Distribution
    USA Nationwide
    Quantity
    190 syringes
    Recall started
    November 9, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0140-2024
  • Class II Ongoing

    Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand,…

    Reason: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

    Padagis US LLC · Trospium Chloride

    Lots, distribution and details
    Product
    Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
    Lots / codes
    Lot: 231104, 231105, 231106, exp 7/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    7,032 bottles
    Recall started
    November 1, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0139-2024
  • Class I Ongoing

    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) b…

    Reason: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

    SUGARMDS LLC

    Lots, distribution and details
    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
    Lots / codes
    LOT# 22165-003, EXP 09/30/2024
    Distribution
    U.S. Nationwide and online websites.
    Quantity
    32,117
    Recall started
    November 8, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0138-2024
  • Class III Terminated

    buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol…

    Reason: Failed Dissolution Specifications

    SUN PHARMACEUTICAL INDUSTRIES INC · Bupropion Hydrochloride

    Lots, distribution and details
    Product
    buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
    Lots / codes
    Lot HAD0630A, exp 1/2024
    Distribution
    Nationwide
    Quantity
    2016 Bottles
    Recall started
    November 22, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0137-2024
  • Class I Ongoing

    Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265

    Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

    Botanical Be

    Lots, distribution and details
    Lots / codes
    All lots, exp 12/12/2024
    Distribution
    USA Nationwide
    Quantity
    300 bottles
    Recall started
    October 20, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0226-2024
  • Class I Ongoing

    Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598

    Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

    Botanical Be

    Lots, distribution and details
    Lots / codes
    All lots, exp 10/20/2024
    Distribution
    USA Nationwide
    Quantity
    —
    Recall started
    October 20, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0225-2024
  • Class I Ongoing

    Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138

    Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

    Botanical Be

    Lots, distribution and details
    Lots / codes
    Lot 35421, exp 12/19/2025
    Distribution
    USA Nationwide
    Quantity
    235 bottles
    Recall started
    October 20, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0224-2024

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 4, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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