The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

24626–24650 of 32189

  • SevereFDA (Drugs)·D-0116-2015·2014-11-05

    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
    PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0109-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Paraben Water for Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Paraben water for injection because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance 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
    Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2015·2014-11-05

    CVS Pain Relieving Antiseptic Spray Recalled for Microbial Contamination

    Wisconsin Pharmacal Company is recalling CVS Pharmacy Pain Relieving Antiseptic Spray because testing revealed microbial growth in the product.

    Product
    CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V707000·2014-11-05

    Blue Bird Recalls 2015 Transit Buses Due to Fuel Filter Defect

    Blue Bird is recalling 2015 All American and Vision transit buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 250 mg/mL injections due to quality control issues that may compromise sterility.

    Product
    Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0161-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix T101, due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T101, 17.65 mg/0.59 mg/5.9 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
  • SevereFDA (Drugs)·D-0057-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Alprostadil Alcohol Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Alprostadil alcohol injectable vials because quality control observations during an FDA inspection presented a risk to sterility assurance.

    Product
    Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including ophthalmic ointment base, due to quality control observations that risk sterility assurance.

    Product
    Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2015·2014-11-05

    Cubicin Injection Recalled for Foreign Particulate Matter in Vials

    Cubist Pharmaceuticals is recalling Cubicin (daptomycin) injection vials due to the presence of tiny black foreign particulate matter observed after reconstitution.

    Product
    CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cefazolin Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Cefazolin eye drops because quality control issues may have compromised sterility.

    Product
    Cefazolin forte 50 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
  • SevereFDA (Drugs)·D-0055-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 20% inhalant solution due to quality control issues affecting sterility assurance.

    Product
    Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0106-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Nalbuphine Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Nalbuphine 10 mg/mL injection solution due to quality control observations that present a risk to sterility assurance.

    Product
    Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable 6000 mcg/mL due to quality control observations that present a risk to sterility assurance.

    Product
    Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2015·2014-11-05

    Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity

    Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0142-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tobramycin Eye Drops for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.

    Product
    Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2015·2014-11-05

    Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities

    Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyclosporine/corn oil, due to quality control observations that risk sterility assurance.

    Product
    Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 250 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 0591-3561-15 UPC 3-3-0591356115-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0231-2015·2014-11-05

    Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns

    Specialty Compounding, LLC is recalling all prescription products manufactured by the company due to a lack of assurance of sterility.

    Product
    All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0157-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST5 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST5 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix ST5, 30 mg/1.5 mg/300 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
  • SevereFDA (Drugs)·D-0146-2015·2014-11-05

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

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

    Product
    Tri-mix, 12 mg/1 mg/9 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
  • SevereFDA (Drugs)·D-0107-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Injectable Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk sterility assurance.

    Product
    "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide