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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.

3,222 recalls

  • Class II Ongoing

    EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

    Reason: CGMP Deviations; potential temperature excursions due to transit delays

    Mckesson Medical-Surgical Inc. Corporate Office · Romosozumab

    Lots, distribution and details
    Lots / codes
    Lot: 1178382, Expiration date: 3/31/2027
    Distribution
    Within the U.S – OH, VA, FL.
    Quantity
    2 Pre-filled syringes
    Recall started
    April 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0539-2025
  • Class II Ongoing

    PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

    Reason: CGMP Deviations; potential temperature excursions due to transit delays

    Mckesson Medical-Surgical Inc. Corporate Office · Denosumab

    Lots, distribution and details
    Lots / codes
    Lot: 1180924, Expiration date: 6/30/2027.
    Distribution
    Within the U.S – OH, VA, FL.
    Quantity
    6 Pre-filled syringes
    Recall started
    April 21, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0538-2025
  • Class II Terminated

    clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

    Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

    Lupin Pharmaceuticals Inc. · Clomipramine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # M300464, exp. date June, 2025
    Distribution
    Nationwide.
    Quantity
    2,724 bottles
    Recall started
    June 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0537-2025
  • Class III Completed

    Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-0…

    Reason: Sub-Potent Drug: Subpotent assay results during stability testing.

    Imprimis NJOF, LLC

    Lots, distribution and details
    Product
    Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
    Lots / codes
    Lot: 25MAR032, Exp. 07/16/2025.
    Distribution
    Nationwide in the USA
    Quantity
    2,890 vials
    Recall started
    July 9, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0536-2025
  • Class II Completed

    Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20×1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

    Reason: Sub-Potent Drug: Subpotent assay results during stability testing.

    Imprimis NJOF, LLC

    Lots, distribution and details
    Product
    Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20×1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
    Lots / codes
    Lot: 24DEC017, Exp. 07/12/2025.
    Distribution
    Nationwide in the USA
    Quantity
    6,880 vials
    Recall started
    July 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0535-2025
  • Class II Ongoing

    Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224

    Reason: CGMP Deviations

    A.P. Deauville, LLC

    Lots, distribution and details
    Product
    Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
    Lots / codes
    Lot # 101225D781, 032926B281, 032826B221, 041126B531, 062226D011, 070626D301, 070626D333, 111026G051, 111326G091, 111626G221
    Distribution
    U.S. Nationwide
    Quantity
    23,467 Cases
    Recall started
    July 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0550-2025
  • Class II Ongoing

    Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194

    Reason: CGMP Deviations

    A.P. Deauville, LLC

    Lots, distribution and details
    Product
    Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
    Lots / codes
    Lot # 031726A991, 041226B561, 062026C901, 062026C911, 071026D351, 071026D361, 071326D391, 111626G231
    Distribution
    U.S. Nationwide
    Quantity
    22,482 Cases
    Recall started
    July 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0549-2025
  • Class II Ongoing

    Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313

    Reason: CGMP Deviations

    A.P. Deauville, LLC

    Lots, distribution and details
    Lots / codes
    Lot # 032026B011, 032226B031, 051626C241, 061526C882, 071226D371, 071226D381, 082526E341, 082826E402
    Distribution
    U.S. Nationwide
    Quantity
    21,265 cases
    Recall started
    July 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0548-2025
  • Class II Ongoing

    Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3×6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

    Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

    Ascend Laboratories, LLC · Rizatriptan Benzoate

    Lots, distribution and details
    Lots / codes
    Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142623, Exp Date: May 2027; Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027.
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    July 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0534-2025
  • Class II Ongoing

    Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3×6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

    Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

    Ascend Laboratories, LLC · Rizatriptan Benzoate

    Lots, distribution and details
    Lots / codes
    Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    July 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0533-2025
  • Class II Ongoing

    Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

    Reason: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

    Lupin Pharmaceuticals Inc. · Lisinopril and Hydrochlorothiazide

    Lots, distribution and details
    Product
    Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
    Lots / codes
    Lot #: QA01081, Exp. Date April 2027
    Distribution
    Product was distributed nationwide within the United States.
    Quantity
    58,968 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0532-2025
  • Class II Ongoing

    PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperi…

    Reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.

    Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

    Lots, distribution and details
    Product
    PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
    Lots / codes
    Lot: a) 11-4785290-0-1, BUD: 6/19/2025 @ 11:32 pm; b) 11-4785217-0-1, BUD: 6/19/2025 @ 10:25 pm.
    Distribution
    CA
    Quantity
    2 bags
    Recall started
    July 1, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0530-2025
  • Class II Ongoing

    Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally – 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Caym…

    Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

    Dr. Reddy's Laboratories, Inc. · Omeprazole

    Lots, distribution and details
    Product
    Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally – 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
    Lots / codes
    Lot: C2403017, Exp 12/31/2026
    Distribution
    USA Nationwide
    Quantity
    1476 bottles
    Recall started
    June 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0525-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17
    Lots / codes
    Lot #D2300042, Exp Date: 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    2,344 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0524-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
    Lots / codes
    Lot #D2300076, Exp Date: 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    4,921 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0523-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
    Lots / codes
    Lot #D2300104, Exp Date: 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    4,896 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0522-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
    Lots / codes
    Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
    Distribution
    Nationwide in the USA
    Quantity
    9,739 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0521-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-24…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15
    Lots / codes
    Lot #D2300087, Exp Date: 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    54,227 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0520-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17
    Lots / codes
    Lot #D2400679, Exp Date: 02/28/2026
    Distribution
    Nationwide in the USA
    Quantity
    2,352 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0519-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2…

    Reason: Subpotent Drug: Assay below the approved specification

    ACCORD HEALTHCARE, INC. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
    Lots / codes
    Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
    Distribution
    Nationwide in the USA
    Quantity
    82,159 bottles
    Recall started
    June 20, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0518-2025
  • Class III Ongoing

    Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

    Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

    Qualgen, LLC

    Lots, distribution and details
    Lots / codes
    Lot number: 1043, Exp. Date 2/10/2026
    Distribution
    Nationwide within the United States.
    Quantity
    2,832 amber vials
    Recall started
    June 16, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0517-2025
  • Class II Ongoing

    Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

    Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

    SUN PHARMACEUTICAL INDUSTRIES INC · Lisdexamfetamine Dimesylate

    Lots, distribution and details
    Product
    Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
    Lots / codes
    Lot # AD42648, Exp 02/28/2026
    Distribution
    Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
    Quantity
    5,448 bottles
    Recall started
    June 16, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0516-2025
  • Class II Ongoing

    In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL – 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin…

    Reason: cGMP deviations

    KABANA SKIN CARE

    Lots, distribution and details
    Product
    In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL – 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
    Lots / codes
    Lot: 408-002
    Distribution
    NJ, FL, MI
    Quantity
    76 bottles
    Recall started
    March 12, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0515-2025
  • Class II Ongoing

    GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care,…

    Reason: cGMP deviations

    KABANA SKIN CARE

    Lots, distribution and details
    Product
    GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
    Lots / codes
    Lots: 405-002 and 405-003
    Distribution
    NJ, FL, MI
    Quantity
    174 tubes
    Recall started
    March 12, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0514-2025
  • Class II Ongoing

    Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1

    Reason: cGMP deviations

    KABANA SKIN CARE

    Lots, distribution and details
    Product
    Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
    Lots / codes
    Lot: 410-002
    Distribution
    NJ, FL, MI
    Quantity
    54 tubes
    Recall started
    March 12, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0513-2025

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 2, 2026 14:41. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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