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.

27251–27275 of 32219

  • SevereFDA (Drugs)·D-66403-004·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 521 bottles of Ciprofloxacin 250 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0116-2014·2013-11-13

    GE Pharma Recalls Creafuse Grape Due to DMAA Contamination

    GE Pharma LLC is recalling 480 units of Creafuse Grape, 600 Grams, because the product contains 1,3 dimethylamylamine (DMAA).

    Product
    Creafuse Grape, 600 Grams
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0094-2014·2013-11-13

    American Laboratories Recalls PC Blend 14 Enzyme Powder Due to Chloramphenicol

    American Laboratories Inc is recalling PC Blend 14 enzyme powder due to potential contamination with Chloramphenicol. The product was distributed to specific states.

    Product
    PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0121-2014·2013-11-13

    KCB Pista Khatie Cookies Recalled for Undeclared Egg Allergen

    Kashmir Crown Baking LLC is recalling Pista Khatie cookies because testing found undeclared egg allergen, despite the label stating the product contains no eggs.

    Product
    KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com a) Net Wt. 30 OZ (850 G) b) Net Wt. 13 OZ (369 G) Packaged in a plastic clam shell container with stick-on labels.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-66403-008·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0125-2014·2013-11-13

    Safeway Recalls Angel Food Cake Loaves Due to Allergen Labeling Errors

    Safeway is recalling Angel Food Cake Loaves because the labels failed to list milk and soy as ingredients.

    Product
    Cake Angel Food Loaf: 1) Cake Angel Food Loaf; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Cake Angel Food Loaf 0 lb. 4 oz. (113 g) Cake Angel Food Loaf Individual loaf sold in…
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-66403-012·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0117-2014·2013-11-13

    GE Pharma Recalls Creafuse Fruit Punch for DMAA Content

    GE Pharma LLC is recalling Creafuse Fruit Punch, 600 Grams, because the product contains 1,3 dimethylamylamine (DMAA).

    Product
    Creafuse Fruit Punch, 600 Grams
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-005·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0102-2014·2013-11-13

    Giant Eagle Candy Corn Mix Recalled for Undeclared Allergens

    Giant Eagle is recalling Candy Place Candy Corn Mix because it contains undeclared milk, egg, peanut, and soy allergens.

    Product
    Giant Eagle Candy Place Candy Corn Mix in a clear plastic container, net wt. 13 oz, Distributed by Giant Eagle Inc. UPC#3003406974
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-66403-011·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-010·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66458-1·2013-11-13

    Sandoz Recalls Ropinirole Extended-Release Tablets Due to Cross-Contamination

    Sandoz is recalling specific lots of Ropinirole Extended-Release Tablets 2 mg due to potential cross-contamination with mycophenolate mofetil.

    Product
    Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules

    Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0095-2014·2013-11-13

    American Laboratories Recalls Ultra Blend 102 Enzyme Powder Due to Contamination

    American Laboratories Inc is recalling Ultra Blend 102 enzyme powder due to potential Chloramphenicol contamination. The product was distributed to five states.

    Product
    Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-66403-009·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0123-2014·2013-11-13

    Safeway Recalls Holiday Angel Food Cakes Due to Missing Allergen Labels

    Safeway is recalling Holiday Decorated Angel Food Cakes because the labels failed to list milk and soy as ingredients.

    Product
    Holiday Decorated Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Holiday Decorated Angel Food Cake  1 lb. 14 oz. (850 g); Black or White Base with Clear Lid…
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-66403-003·2013-11-13

    Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66318-001·2013-11-13

    Amgen Recalls Prolia Injection Due to Visible Cellulose Fibers

    Amgen is recalling 4,163 Prolia (denosumab) prefilled syringes because visible cellulose fibers were found during routine quality checks.

    Product
    PROLIA — PROLIA (DENOSUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66447-001·2013-11-13

    Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

    West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide