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.

13776–13800 of 21617

  • ModerateFDA (Drugs)·D-0028-2017·2016-10-19

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 10 syringes of Buffered Lidocaine 2% because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0032-2017·2016-10-19

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 210 syringes of Fentanyl Citrate and Bupivacaine HCl because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0067-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 512 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0030-2017·2016-10-19

    Pharmedium Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,478 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2017·2016-10-19

    PharMEDium Recalls Lidocaine Syringes Due to Stability Data Concerns

    PharMEDium is recalling 499 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2017·2016-10-19

    A&D Blood Pressure Monitors Recalled for Small Cuff Labeling Error

    A&D Engineering is recalling 378 blood pressure monitors that were not labeled for use with small cuffs. The devices were distributed to distributors in New York, Massachusetts, Virginia, and Texas.

    Product
    Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0081-2017·2016-10-19

    Chaos and Pain Recalls Cannibal Riot Pre-Workout for Undeclared Ingredients

    Chaos and Pain is recalling Cannibal Riot pre-workout supplements because they contain undeclared Agmatine and 1,3 Dimethylbutylamine, which is not permitted in the EU.

    Product
    CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, FIVE FINGER DEATH PUNCH, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314652
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0086-2017·2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 498 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0037-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns

    Pharmedium Services, LLC is recalling 53,357 syringes of fentanyl citrate injection because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0068-2017·2016-10-19

    Surgical Specialties Recalls BioSentry Tract Sealant System Due to Packaging Defect

    Surgical Specialties Mexico is recalling the BioSentry Tract Sealant System because the product packages may have open seals.

    Product
    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0062-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 499 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2017·2016-10-19

    Pharmedium Recalls Remifentanil Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,623 syringes of remifentanil HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0099-2017·2016-10-19

    Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

    Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05% because it failed content uniformity specifications. The recall covers 25,247 tubes distributed nationwide.

    Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0045-2017·2016-10-19

    Wegmans Organic Blush Sauce Recalled for Incorrect Milk Allergen Labeling

    LiDestri Foods is recalling Wegmans Organic Blush Sauce because jars were labeled with a cream sauce allergen declaration for milk.

    Product
    Wegmans ITALIAN CLASSICS Organic BLUSH SAUCE, NET WT 23.5 OZ (1 LB 7.5 OZ) 667g
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0043-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate syringes because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0082-2017·2016-10-19

    Chaos and Pain Recalls Cannibal Riot Pre-Workout for Undeclared Ingredients

    Chaos and Pain is recalling Cannibal Riot pre-workout supplements because they contain undeclared Agmatine and 1,3 Dimethylbutylamine, which is not permitted in the EU.

    Product
    CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, UNICORN BLOOD, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314669
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0076-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 3,270 syringes of morphine sulfate due to stability data that does not support the expiry date, posing a potential loss of potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0035-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services is recalling 8,955 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0066-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 830 syringes of lidocaine HCl, 2%, preservative-free, because stability data does not support the expiry dates, posing a risk of potential loss of potency.

    Product
    lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2017·2016-10-19

    Teleflex Gripper Graspers Recalled for Labeling Error

    Teleflex Medical is recalling 160 Gripper Graspers due to a labeling error where they were mislabeled as Johans Graspers.

    Product
    Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0054-2017·2016-10-19

    Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,500 syringes of ketamine HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0044-2017·2016-10-19

    Pharmedium Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 16,366 syringes of glycopyrrolate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0063-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 5,900 syringes of lidocaine HCl 1% because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0069-2017·2016-10-19

    Supermom's Kitchen Roast Beef Melt Recalled for Undeclared Ingredients

    Northern Tier Bakery is recalling Supermom's Kitchen Roast Beef & Cheddar Melt because the product was mislabeled and failed to declare monosodium glutamate, yellow 5, and yellow 6.

    Product
    Supermoms Kitchen Roast Beef & Cheddar Melt, Net Wt. 3.7 oz (105g). Keep Refrigerated. UPC 63913-94236
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0055-2017·2016-10-19

    Pharmedium Recalls Ketamine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 9,101 syringes of ketamine HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.
    Category
    Drug
    Distribution
    Distributed nationwide