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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.

5 recalls

  • Class II Ongoing

    Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy…

    Reason: Incorrect product formulation: bag did not contain copper and famotidine per label.

    Central Admixture Pharmacy Services, Inc.

    Lots, distribution and details
    Product
    Total Parental Nutrition – Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
    Lots / codes
    24-1269856-0-1
    Distribution
    MA
    Quantity
    One (1) patient-specific TPN prescription.
    Recall started
    June 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0618-2026
  • Class II Ongoing

    GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

    Reason: Lack of Assurance of Sterility

    GenoGenix LLC

    Lots, distribution and details
    Lots / codes
    All lots within expiry.
    Distribution
    US Nationwide.
    Quantity
    221
    Recall started
    July 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0051-2026
  • Class II Terminated

    Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 m…

    Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

    Curium US, LLC · Technetium Tc 99m Sestamibi

    Lots, distribution and details
    Product
    Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 mg; Stannous Chloride Dihydrate – 0.D75 mg; L-Cysteine Hydrochloride Monohydrate – 1 mg; Sodium Citrate Dihydrate – 2.6 mg; Mannitol – 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
    Lots / codes
    Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
    Distribution
    Nationwide USA and Canada.
    Quantity
    5,160 vials (172 kits 30 vials/kit)
    Recall started
    November 26, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0164-2025
  • Class II Ongoing

    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 209611…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 2007524, 2096102, 2096111, 2096117, 2097635, 2097636, 2099592, 2007523, 2096096, 2097632, 2097655, 2097794, 2097144, 2096124, 2096130, 2097637, 2096101, 2097141, 2097083, 2008234, 2096099, 2097084; 2006432
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1365-2022
  • Class II Ongoing

    Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

    Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

    Lowlite Investments, Inc. D/B/A Olympia Pharmacy

    Lots, distribution and details
    Lots / codes
    L5610 exp 11/30/13
    Distribution
    Nationwide and PR
    Quantity
    1
    Recall started
    May 29, 2013 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-709-2013

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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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