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.

40176–40200 of 50506

  • HighFDA (Drugs)·D-0128-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix, due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0079-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Dihydroergotamine Mesylate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling dihydroergotamine mesylate injections due to quality control issues that may compromise sterility assurance.

    Product
    Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0168-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Vancomycin Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Vancomycin 25 mg/mL ophthalmic solution because quality control issues may compromise sterility.

    Product
    Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2015·2014-11-05

    SAM Medical Products Recalls Junctional Tourniquet Auxiliary Straps

    Sam Medical Products is recalling SJT 102 and 112 auxiliary straps because the snap hook broke during a training demonstration.

    Product
    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix 8.3 low dose, due to quality control issues affecting sterility assurance.

    Product
    Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0150-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2015·2014-11-05

    Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects

    Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.

    Product
    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because FDA inspection findings raised concerns about sterility assurance.

    Product
    Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0097-2015·2014-11-05

    Heather's Choice Recalls Salmon Chowder for Undeclared Coconut and Permit Issues

    Heather's Choice is recalling Salmon Chowder because the firm operated without a permit and lacked a HACCP plan. The product also contains undeclared coconut.

    Product
    Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: "***Salmon Chowder***HEATHER'S CHOICE***meals for adventuring***ingredients: salmon + peas + carrots + potatoes+ coconut milk powder***directions: cover food with hot water + let sit for 15…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0069-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0087-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydrochloric acid/water for injection, due to quality control observations that present a risk to sterility assurance.

    Product
    Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc is voluntarily recalling 26,663 cartons of Vancomycin Hydrochloride Capsules because the drug was found to be subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0164-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix T106 injectable vials because FDA inspection observations raised concerns about sterility assurance.

    Product
    Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0088-2015·2014-11-05

    Ikea Recalls Elk-Shaped Wholemeal Pasta Due to Undeclared Soy

    Ikea North America is recalling 22,025 units of elk-shaped wholemeal pasta because the product contains undeclared soy.

    Product
    Elk shaped pasta Ekologiska PASTA-ALGAR FULLKORN Pasta elks wholemeal, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FOR: IKEA FOOD SERVICES
    Category
    Food
    Distribution
    21 states
  • HighFDA (Drugs)·D-0159-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix ST9-B, due to quality control issues affecting sterility assurance.

    Product
    Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Prednisolone Acetate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Prednisolone acetate 50 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Atropine Sulfate Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 1 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0094-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Hydroxyzine Hydrochloride Injectable Vials

    Martin Avenue Pharmacy is voluntarily recalling Hydroxyzine hydrochloride 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2015·2014-11-05

    Martin Avenue Pharmacy Recalls PGE 3 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling PGE 3 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL..
    Category
    Drug
    Distribution
    Distributed nationwide