The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

17326–17350 of 53124

  • HighFDA (Drugs)·D-0911-2022·2022-06-01

    Testosterone Cypionate Injectable Vials Recalled Due to Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalls Testosterone Cypionate injectable vials distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.

    Product
    Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0934-2022·2022-06-01

    Injectable drug recalled for lack of sterility assurance

    Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0937-2022·2022-06-01

    MICC Injectable Drug Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0949-2022·2022-06-01

    FDA Recalls Amino Blend Injectable Vials Due to Sterility Concerns

    Olympia Compounding Pharmacy is recalling Amino Blend injectable vials due to lack of assurance of sterility. Approximately 7,761 vials were distributed nationwide. The FDA has classified this as a Class II recall.

    Product
    Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.NDC 73198-0129-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0901-2022·2022-06-01

    Olympia Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Sterility Concerns

    Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.

    Product
    SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0924-2022·2022-06-01

    Dexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure

    Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.

    Product
    Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0891-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity

    Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0912-2022·2022-06-01

    FDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.

    Product
    Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0926-2022·2022-06-01

    Injectable Folic Acid and Hydroxocobalamin Recalled Due to Sterility Concerns

    Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.

    Product
    Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0940-2022·2022-06-01

    Injectable pharmaceutical vial recalled due to sterility assurance failure

    Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.

    Product
    NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V391000·2022-06-01

    Elgin RegenX Vehicles Recalled for Loose Fan Assembly Bolts

    Elgin Sweeper is recalling 2018-2022 RegenX vehicles because improperly tightened fan assembly bolts may detach, creating a road hazard and increasing crash risk.

    Product
    ELGIN — ELGIN REGENX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0915-2022·2022-06-01

    Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues

    Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.

    Product
    Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0893-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits

    Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0946-2022·2022-06-01

    Pyridoxine Injection Vials Recalled Due to Sterility Concerns

    Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2022·2022-06-01

    Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.

    Product
    Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2022·2022-06-01

    Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers

    Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.

    Product
    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2022·2022-06-01

    HydroMARK Breast Biopsy Marker Label Mismatch on Patient Documentation

    Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.

    Product
    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0885-2022·2022-06-01

    Losartan HCTZ Medication Recalled for Elevated AZIDO Impurity

    RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.

    Product
    Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1126-2022·2022-06-01

    Gibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes

    Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.

    Product
    (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0903-2022·2022-06-01

    Pharmaceutical Diluent Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2022·2022-06-01

    Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity

    Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.

    Product
    Surgical Suture Kit
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0938-2022·2022-06-01

    Myers Cocktail Injectable Vials Recalled for Sterility Assurance Issues

    Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.

    Product
    Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V389000·2022-05-31

    TM Industries Recalls 2021-2022 TrailManor 2518 Series Travel Trailers

    TM Industries is recalling 2021-2022 TrailManor 2518 series travel trailers because damaged burner control valves may cause a gas leak, increasing the risk of fire.

    Product
    TRAILMANOR — TRAILMANOR 2518 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V387000·2022-05-30

    2021-2022 Escape Travel Trailers Recalled for Cracked LP Gas Fittings

    Escape Trailer is recalling 2021-2022 Escape travel trailers (models 17, 19, 21, and 5.0TA) due to cracked quick disconnect fittings in the LP gas system that may cause a gas leak and fire hazard.

    Product
    ESCAPE — ESCAPE ESCAPE 19, ESCAPE 5.0, ESCAPE 17, ESCAPE 21
    Category
    Vehicle
    Distribution
    Distributed nationwide