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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

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

3,228 recalls

  • Class II Ongoing

    BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot # MN23323, Exp. Date Jul 2028; MN31323, Exp. Date Oct 2028; MN21622, Exp. Date Jul 2027; MN13123, Exp. Date Apr 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0367-2026
  • Class II Ongoing

    Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302624, MN302724, MN303324, Exp. Date Dec 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0366-2026
  • Class II Ongoing

    Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN15922, Exp. Date Apr 2027; MN31022, Exp. Date Oct 2027; MN27223, Exp. Date 2028-Aug.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0365-2026
  • Class II Ongoing

    Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN24623, Exp. Date Jul 2028; MN27023, Exp. Date Aug 2028; MN32423, Exp. Oct 2028; MN300724, Exp. Date Dec 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0364-2026
  • Class II Ongoing

    Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4×7, Max Packaging, Made in the USA, NDC 59647-750-01

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN24523, Exp. Date July 2028; MN27123, Exp. Date Aug 2028; MN28223, Exp. Date Sep 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0363-2026
  • Class II Ongoing

    1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towel…

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Product
    1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging – Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta
    Lots / codes
    1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222 Exp. Date Apr 2027-Apr; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug 2028. 3) Lot #: MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222, Exp. Date Apr 2027; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug2028. 4) Lot#: MN04423, Exp. Date Jan 2028; MN10022, Exp. Date Jul 2027; MN30722, Exp. Date Oct 2027; MN03523, Exp. Date Jan 2028; MN09323, Exp. Date Mar 2028; MN20223, Exp. Date July 2028; MN32223, Exp. Date Oct 2028 5) Lots MN12122 2027-Apr, MN27523 2028-Aug & MN30922 2027-Oct.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0362-2026
  • Class II Ongoing

    First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5×7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; MN02022, MN03022, Exp. Date Dec 2026; MN03522, MN04622, Exp. Date Jan 2027; MN06022, MN06122, Exp. Date Feb 2027; MN12322, MN12422, MN14422, Exp. Date Apr 2027; MN15322, Exp. May 2027; MN22022, Exp. Date Jul 2027; MN25222, MN25322, MN26422, Exp. Date Aug 2027; MN27822, Exp. Date Sep 2027; MN15322, Exp. Date Nov 2027; MN06123, Exp. Date Aug 2027; MN06423, MN06523, Exp. Date Feb 2028; MN09423, MN09523, MN09723, MN10223 Exp Date Mar 2028; MN12623, MN13323, Exp. Date Apr 2028; MN15322, MN16523, Exp. Date May 2028; MN18623, MN19323, MN19423, MN20223, Exp. Date Jun 2028; MN24323, MN24423 Exp. Date Jul 2028; MN34523, Exp. Date Nov 2028; 301424, 301524, 301624, 301724, 303124, Exp. Date Dec 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0361-2026
  • Class II Ongoing

    Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0360-2026
  • Class II Ongoing

    First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN34722, MN34722, Exp. Date Nov 2027; MN34722B, Exp. Date Aug 2027.
    Distribution
    Nationwide within the United States
    Quantity
    N/A
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0359-2026
  • Class II Ongoing

    First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

    Reason: CGMP Deviations

    ACME UNITED CORPORATION

    Lots, distribution and details
    Lots / codes
    Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.
    Distribution
    Nationwide within the United States
    Quantity
    212,607,900 containers
    Recall started
    January 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0358-2026
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .
    Distribution
    Nationwide
    Quantity
    19,056 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0357-2026
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
    Distribution
    Nationwide
    Quantity
    7,448 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0356-2026
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
    Distribution
    Nationwide
    Quantity
    67,043 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0355-2026
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
    Distribution
    Nationwide
    Quantity
    18,780 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0354-2026
  • Class II Ongoing

    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 – Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India – 380014, Email:info@omnilens.in, Manufac…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 – Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India – 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    184,320 containers
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0352-2026
  • Class II Ongoing

    Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 – Samruddhi, Opp. Sakar – III, Navrangpura, Ahmedabad – 380014, India, Email:info@omnilens.in, Manufactured for &…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 – Samruddhi, Opp. Sakar – III, Navrangpura, Ahmedabad – 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    50,400 Boxes
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0351-2026
  • Class II Ongoing

    CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bh…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited · Fluorescein Sodium

    Lots, distribution and details
    Product
    CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    10,080 boxes
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0350-2026
  • Class II Ongoing

    Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    139,104 cartons
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0349-2026
  • Class II Ongoing

    Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufacture…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    11,520 cartons
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0348-2026
  • Class II Ongoing

    Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    17,280 cartons
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0347-2026
  • Class II Ongoing

    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhh…

    Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

    Wizcure Pharmaa Private Limited

    Lots, distribution and details
    Product
    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
    Lots / codes
    All lots
    Distribution
    Distributed Nationwide in the USA
    Quantity
    5,760 cartons
    Recall started
    December 31, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0346-2026
  • Class II Ongoing

    Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

    Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

    Agebox

    Lots, distribution and details
    Lots / codes
    Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028
    Distribution
    The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
    Quantity
    N/A
    Recall started
    October 28, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0345-2026
  • Class II Ongoing

    Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

    Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

    Agebox

    Lots, distribution and details
    Lots / codes
    Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
    Distribution
    The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
    Quantity
    665 bottles
    Recall started
    October 28, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0344-2026
  • Class III Ongoing

    Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1×100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Are…

    Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

    Slate Run Pharmaceuticals · Eptifibatide

    Lots, distribution and details
    Product
    Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1×100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide within the USA.
    Quantity
    N/A
    Recall started
    February 12, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0343-2026
  • Class II Ongoing

    Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

    Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

    AvKARE · Amantadine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # 49261, Exp: 04/30/27
    Distribution
    Nationwide in the USA.
    Quantity
    N/A
    Recall started
    February 13, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0341-2026

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 November 1, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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