The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

11526–11550 of 21617

  • ModerateFDA (Drugs)·D-0154-2018·2018-01-17

    Allergan Recalls One Lot of Viokace Tablets Due to Stability Testing Failures

    Allergan is recalling one lot of Viokace tablets because stability testing results did not meet specifications for enzyme profile.

    Product
    Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0169-2018·2018-01-17

    KRS Global Biotechnology Recalls Chloramphenicol Otic Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Chloramphenicol 50 mg/Sulfamethoxazole 50 mg/Amphotericin-B 5 mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0196-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Acetate Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 157 vials of Sermorelin Acetate/GHRP6 due to incorrect or missing lot and expiration dates.

    Product
    Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0177-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 7,862 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0197-2018·2018-01-17

    KRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 898 vials of Sincalide 5 mcg due to incorrect or missing lot and expiration dates.

    Product
    Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0200-2018·2018-01-17

    KRS Global Biotechnology Recalls T-105 Vials Due to Expired Ingredient Dates

    KRS Global Biotechnology is recalling 173 vials of T-105 because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0558-2018·2018-01-17

    Bush's Best Baked Beans Recalled Due to Swollen Cans

    Bush Brothers & Co is recalling Bush's Best Baked Beans because some cans were found to be swollen. The product was distributed to five states.

    Product
    BUSH'S BEST¿ Original SEASONED WITH BACON & BROWN SUGAR BAKED BEANS 55 OZ (3 LB 7 OZ) 1.56 kg BUSH BROTHERS & COMPANY P.O. Box 52330, Dep. C KNOXVILLE, TN 37950-2330
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0166-2018·2018-01-17

    KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredients

    KRS Global Biotechnology is recalling 1,380 jars of Benzocaine, Lidocaine, and Tetracaine Topical Cream because the product's beyond-use date exceeds the expiration dates of its ingredients.

    Product
    Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0648-2018·2018-01-17

    Spice Chain Recalls Paprika Powder Due to Beetle Complaints

    Spice Chain Corporation is recalling Krasdale Paprika Powder after consumers reported finding beetles in retail containers.

    Product
    Paprika Powder Krasdale 12/2.75oz, Krasdale
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0194-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Cartridges Due to Labeling Errors

    KRS Global Biotechnology is recalling 80 Sermorelin cartridges because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2018·2018-01-17

    KRS Global Biotechnology Recalls Amphotericin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 80 vials of Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0198-2018·2018-01-17

    KRS Global Biotechnology Recalls Trimix #22F Due to Labeling Errors

    KRS Global Biotechnology is recalling 235 vials of Trimix #22F because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0190-2018·2018-01-17

    KRS Global Biotechnology Recalls QUADMIX #17 Due to Expired Ingredients

    KRS Global Biotechnology is recalling 122 vials of QUADMIX #17 because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0202-2018·2018-01-17

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors

    KRS Global Biotechnology is recalling 81 droptainers of a multi-dose ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0205-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial due to incorrect or missing lot and expiration dates.

    Product
    Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0192-2018·2018-01-17

    FDA Recalls Savinase Topical Solution Due to Expired Ingredient Labeling

    KRS Global Biotechnology is recalling Savinase 100 mcg/mL Topical Solution because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0207-2018·2018-01-17

    KRS Global Biotechnology Recalls 7-Keto DHEA Capsules Due to Labeling Error

    KRS Global Biotechnology is recalling 7-Keto DHEA 25mg capsules because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0213-2018·2018-01-17

    Dr. Reddy's Recalls Docetaxel Injection Vials Due to Seal Defects

    Dr. Reddy's is recalling 1,051 vials of Docetaxel Injection USP due to defects in the vial seals that may allow the stopper to detach.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0209-2018·2018-01-17

    Prinston Recalls Valsartan Tablets Due to Physical Specification Failures

    Prinston Pharmaceutical Inc. is recalling 21,987 bottles of Valsartan 160 mg tablets because customer complaints confirmed the tablets were thicker and heavier than specifications.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0173-2018·2018-01-17

    KRS Global Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error

    KRS Global Biotechnology is recalling 2,239 Human Chorionic Gonadotropin tablets because the expiration date exceeds the shelf life of an ingredient.

    Product
    Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0199-2018·2018-01-17

    KRS Global Biotechnology Recalls Trimix #23F Due to Incorrect Expiration Date

    KRS Global Biotechnology is recalling 94 vials of Trimix #23F because the product's expiration date exceeds the expiration date of at least one ingredient.

    Product
    Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0179-2018·2018-01-17

    KRS Global Biotechnology Recalls Hydroquinone and Tretinoin Ointment Jars

    KRS Global Biotechnology is recalling 30 jars of Hydroquinone 8%/Tretinoin 0.1% Topical Ointment because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide