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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

    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 38317300…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.
    Lots / codes
    Lot# 20240730, Exp Date: 07/30/2026.
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0463-2026
  • Class II Ongoing

    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 38317300…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.
    Lots / codes
    Lot# 20240524, Exp Date: 05/24/2026.
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0462-2026
  • Class II Ongoing

    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, U…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085
    Lots / codes
    Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026.
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0461-2026
  • Class II Ongoing

    Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Lots / codes
    Lot # 20241030, Exp Date: 10/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0460-2026
  • Class II Ongoing

    Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.
    Lots / codes
    Lot # 20241030, Exp Date: 10/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0459-2026
  • Class II Ongoing

    caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 8100…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
    Lots / codes
    Lot # 20241030, Exp Date: 10/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0458-2026
  • Class II Ongoing

    exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Ma…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
    Lots / codes
    Lot # 20241030, Exp Date: 10/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0457-2026
  • Class II Ongoing

    exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL…

    Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

    Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

    Lots, distribution and details
    Product
    exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.
    Lots / codes
    Lot # 20241030, Exp Date: 10/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0456-2026
  • Class II Ongoing

    SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz – 21 mL and b) 1.5 fl. oz. – 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.

    Reason: Chemical contamination: Presence of benzene

    Owen Biosciences Inc.

    Lots, distribution and details
    Lots / codes
    Lot# 2691700, Exp.10/31/2027 Lot# 2691800, Exp. 11/4/2027
    Distribution
    U.S. Nationwide
    Quantity
    2,500 bottles
    Recall started
    March 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0455-2026
  • Class II Ongoing

    SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz – 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.

    Reason: Chemical contamination: Presence of benzene

    Owen Biosciences Inc.

    Lots, distribution and details
    Lots / codes
    Lot# 2567200, Exp.8/1/26 Lot# 2691600, Exp.10/30/2027
    Distribution
    U.S. Nationwide
    Quantity
    2269 bottles
    Recall started
    March 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0454-2026
  • Class II Ongoing

    HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027

    Reason: Chemical contamination: Presence of benzene

    Owen Biosciences Inc.

    Lots, distribution and details
    Lots / codes
    Lot# 2518800, Exp.: 4/30/2027 Lot# 2518900, Exp.: 4/1/2027
    Distribution
    U.S. Nationwide
    Quantity
    9,850 bottles
    Recall started
    March 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0453-2026
  • Class II Ongoing

    FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas

    Reason: Chemical contamination: Presence of benzene

    Owen Biosciences Inc.

    Lots, distribution and details
    Lots / codes
    Lot #2595500, Exp.10/2/2026 Lot #2549700, Exp.6/12/2026 Lot #2638200, Exp.4/30/2027
    Distribution
    U.S. Nationwide
    Quantity
    7,975 tubes
    Recall started
    March 3, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0452-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND…

    Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
    Lots / codes
    Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
    Distribution
    Nationwide in the USA
    Quantity
    63,192 bottles
    Recall started
    March 16, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0451-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND…

    Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
    Lots / codes
    Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
    Distribution
    Nationwide in the USA
    Quantity
    96,096 bottles
    Recall started
    March 16, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0450-2026
  • Class II Ongoing

    Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. ND…

    Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

    Cipla USA, Inc. · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
    Lots / codes
    Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027
    Distribution
    Nationwide in the USA
    Quantity
    113,336 bottles
    Recall started
    March 16, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0449-2026
  • Class II Ongoing

    Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…

    Reason: CGMP Deviations: use of an unapproved raw material

    Teva Pharmaceuticals USA, Inc · Clonidine

    Lots, distribution and details
    Product
    Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
    Lots / codes
    Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
    Distribution
    Within U.S
    Quantity
    113,943 Cartons
    Recall started
    March 19, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0474-2026
  • Class II Ongoing

    Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…

    Reason: CGMP Deviations: use of an unapproved raw material

    Teva Pharmaceuticals USA, Inc · Clonidine

    Lots, distribution and details
    Product
    Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
    Lots / codes
    Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
    Distribution
    Within U.S
    Quantity
    62,136 Cartons
    Recall started
    March 19, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0473-2026
  • Class II Ongoing

    Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc…

    Reason: CGMP Deviations: use of an unapproved raw material

    Teva Pharmaceuticals USA, Inc · Clonidine

    Lots, distribution and details
    Product
    Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch
    Lots / codes
    Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
    Distribution
    Within U.S
    Quantity
    124,054 Cartons
    Recall started
    March 19, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0472-2026
  • Class II Ongoing

    GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

    Reason: Presence of particulate matter

    GE Healthcare Ireland Limited · Iohexol

    Lots, distribution and details
    Lots / codes
    Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029
    Distribution
    U.S. Nationwide.
    Quantity
    306,810 vials
    Recall started
    March 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0448-2026
  • Class II Ongoing

    GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

    Reason: Presence of particulate matter

    GE Healthcare Ireland Limited · Iohexol

    Lots, distribution and details
    Lots / codes
    Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028
    Distribution
    U.S. Nationwide.
    Quantity
    866,570 vials
    Recall started
    March 24, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0447-2026
  • Class II Ongoing

    Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

    Reason: Superpotent and Subpotent

    Teva Pharmaceuticals USA, Inc · Isotretinoin

    Lots, distribution and details
    Lots / codes
    Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
    Distribution
    FL, OH, PR & MS
    Quantity
    8376 packages
    Recall started
    January 12, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0446-2026
  • Class II Ongoing

    Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

    Reason: Superpotent and Subpotent

    Teva Pharmaceuticals USA, Inc · Isotretinoin

    Lots, distribution and details
    Lots / codes
    Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
    Distribution
    FL, OH, PR & MS
    Quantity
    21984 packages
    Recall started
    January 12, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0445-2026
  • Class II Ongoing

    Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

    Reason: Failed Dissolution Specifications

    Viatris, Inc.

    Lots, distribution and details
    Lots / codes
    Lot# 8177156, Exp Date: 02/28/2027
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    March 17, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0444-2026
  • Class II Ongoing

    Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

    Reason: Lack of Assurance of Sterility

    Preferred Pharmaceuticals, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M
    Distribution
    Nationwide within the United States
    Quantity
    720 bottles
    Recall started
    March 25, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0443-2026
  • Class II Ongoing

    Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01

    Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

    Fagron Compounding Services · Vancomycin Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
    Distribution
    Nationwide in the U.S.A.
    Quantity
    11,680 bags
    Recall started
    March 20, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0442-2026

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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