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.

17301–17325 of 53124

  • HighFDA (Drugs)·D-0906-2022·2022-06-01

    FDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.

    Product
    Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0947-2022·2022-06-01

    Compounded Injectable Medication Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.

    Product
    QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0930-2022·2022-06-01

    Lidocaine 2% injectable solution recalled for lack of sterility assurance

    Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.

    Product
    Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0904-2022·2022-06-01

    Sodium Bicarbonate 8.4% Injectable Recalled Over Sterility Assurance Concerns

    Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2022·2022-06-01

    Medical beds with motorized wheels face uncontrolled motion risk

    Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.

    Product
    AC-powered adjustable medical beds with built-in electric DC actuators and controls.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0909-2022·2022-06-01

    FDA Recalls Compounded Papaverine Injection Due to Sterility Assurance

    Olympia Compounding Pharmacy is recalling T-105 Papaverine injection vials due to lack of assurance of sterility. The recall affects 3,312 vials distributed nationwide.

    Product
    T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2022·2022-06-01

    Compounded injectable medication recalled for sterility assurance failure

    Olympia Compounding Pharmacy is recalling QM-3, a multi-dose compounded injectable, due to lack of sterility assurance. The recall includes 414 vials distributed nationwide.

    Product
    QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2022·2022-06-01

    Protekt Sharps Safety Knives with Incorrect Size Label

    International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.

    Product
    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0907-2022·2022-06-01

    FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.

    Product
    Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0916-2022·2022-06-01

    FDA Recalls Zinc Chloride Injectable Due to Sterility Concerns

    Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride injectable nationwide due to lack of assurance of sterility.

    Product
    Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2022·2022-06-01

    Medtronic Cardioblate Gemini-s Surgical Ablation System Recalled for Fractured Jaw Tips

    Medtronic is recalling 1,236 units of the Cardioblate Gemini-s surgical ablation system due to an increase in complaints about fractured jaw tips. The device is used in cardiac ablation procedures worldwide.

    Product
    Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0894-2022·2022-06-01

    Blood Pressure Medication Recalled for Manufacturing Impurity

    Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1134-2022·2022-06-01

    SUR-FIT Natura Durahesive Wafer Recalled for Skin Barrier Delamination

    ConvaTec is recalling 600 market units of SUR-FIT Natura S4S Durahesive Wafer due to skin barrier delamination. The wafer's layers or tape borders may fail to maintain proper seal, potentially affecting skin protection.

    Product
    SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0939-2022·2022-06-01

    FDA recalls NAD+ pharmaceutical powder vials due to sterility concerns

    Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide powder vials nationwide due to lack of assurance of sterility. The recall affects 8,982 vials distributed across the USA, Puerto Rico, and US Virgin Islands.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1083-2022·2022-06-01

    HEB Bakery Two-Bite Brownies recalled for potential metal fragments

    H-E-B Grocery Company recalls HEB Bakery Two-Bite Brownies due to potential metal fragments in the product. Affected packages were distributed in Texas.

    Product
    HEB Bakery Two-Bite Brownies NET WT 12 OZ (340g) UPC 0471220109517 packaged in plastic clamshell container 24 packages per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1137-2022·2022-06-01

    Progenamatrix Human Keratin Matrix Recalled for Inadequate Pouch Seal

    ProgenaCare is recalling progenamatrix Human Keratin Matrix due to inadequate inner pouch seals that may compromise sterility. The recall affects 547 packages distributed in Alabama, Georgia, Florida, Tennessee, and Texas.

    Product
    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0889-2022·2022-06-01

    Prescription Drug Daytrana Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches from Lot 90764 (expiration 08/2022) distributed nationwide due to defects in the delivery system. The recall was initiated after customer complaints exceeded FDA action limits.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0932-2022·2022-06-01

    Lipo-Mino-Mix Injectable Compounded Drug Recalled for Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.

    Product
    Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0922-2022·2022-06-01

    Cyanocobalamin Injectable Vials Recalled Due to Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.

    Product
    Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0944-2022·2022-06-01

    FDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns

    Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.

    Product
    PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0928-2022·2022-06-01

    Formula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.

    Product
    Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2022·2022-06-01

    INTERTAN 1.5 nail orthopedic implants recalled due to reversed left-right labeling

    Smith & Nephew is recalling INTERTAN 1.5 nails because right nails were marked and labeled as left nails, and vice versa. This mislabeling could lead to incorrect surgical placement.

    Product
    INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0929-2022·2022-06-01

    Compounded Injectable Medication Recalled Due to Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.

    Product
    Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0913-2022·2022-06-01

    Tri-Immune Boost Injectable Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling 2,260 vials of Tri-Immune Boost injectable supplement due to lack of sterility assurance. Distribution was nationwide, including Puerto Rico and US Virgin Islands.

    Product
    Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30
    Category
    Drug
    Distribution
    Distributed nationwide