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.

13751–13775 of 21617

  • ModerateFDA (Drugs)·D-0033-2017·2016-10-19

    Fentanyl Citrate Injection Recalled Due to Potential Loss of Potency

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

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0060-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,961 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0061-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 500 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a risk of loss of potency.

    Product
    lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0041-2017·2016-10-19

    Schafer Fisheries Recalls Gefilte Fish Due to HACCP Record Deficiencies

    Schafer Fisheries is recalling 250 cases of Twin Fin Deli Gefilte Fish because the company lacked adequate HACCP records. The product was distributed in Illinois, New York, and California.

    Product
    Label reads in part: TWIN FIN DELI; Gefilte Fish; Kosher Fish Products Inc., Fulton, IL. FDA# 1481764; Net WT. 24 OZ (680G)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0027-2017·2016-10-19

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 660 syringes of Buffered Lidocaine because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0084-2017·2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Targeting Arm Surgical Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Targeting Arm surgical instruments because old and new revisions are not interchangeable, potentially causing surgical delays.

    Product
    Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0089-2017·2016-10-19

    Pharmedium Recalls Rocuronium Bromide Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 6,970 syringes of rocuronium bromide because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0058-2017·2016-10-19

    Pharmedium Recalls Labetalol HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 969 syringes of labetalol HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0079-2017·2016-10-19

    RaySearch Radiation Therapy Treatment Planning System Software Recall

    RaySearch Laboratories is recalling Model 5.0 software due to a bug that may display incorrect dose statistics in treatment plan reports.

    Product
    Radiation Therapy Treatment Planning System, Model 5.0
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0064-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 300 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), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0050-2017·2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,916 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 616 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0045-2017·2016-10-19

    Pharmedium Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 17,462 syringes of glycopyrrolate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2017·2016-10-19

    Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 5,568 syringes of atropine sulfate injection because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2017·2016-10-19

    Pharmedium Recalls Ephedrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 995 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    ePHEDrine Sulfate, 5 mg per mL, 25 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 2R3301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0066-2017·2016-10-19

    Winco TMM5 Mobile Surgical Stretcher-Chair Recalled for Design Non-Conformance

    Winco Mfg. is recalling 264 TMM5 Series Mobile Surgical Stretcher-Chairs because non-conforming components caused the arms to no longer meet design specifications.

    Product
    TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0059-2017·2016-10-19

    Teleflex Johans Grasper Recall Due to Labeling Error

    Teleflex Medical is recalling 160 Johans Graspers because they were mislabeled as Gripper Graspers. The sterile surgical instruments were distributed to six US states.

    Product
    Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, 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-0074-2017·2016-10-19

    Pharmedium Recalls Midazolam HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,058 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0068-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,161 syringes of lidocaine HCl 2% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2017·2016-10-19

    Pharmedium Recalls Glycopyrrolate Syringes Due to Insufficient Stability Data

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

    Product
    glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0072-2017·2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 7,556 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0040-2017·2016-10-19

    Schafer Fisheries Recalls Twin Fin Deli Salami Due to Recordkeeping Issues

    Schafer Fisheries is recalling Twin Fin Deli Salami because the company lacked adequate HACCP records. The product was distributed in Illinois, New York, and California.

    Product
    Label reads in part: TWIN FIN DELI; Salami; Net WT. 1lb (453g); P.O. Box 399 Thomson IL, FDA# 1481764 Thomason
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0051-2017·2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,860 syringes of Hydromorphone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0059-2017·2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 3,285 syringes of lidocaine HCl because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0044-2017·2016-10-19

    Doctor Kracker Crispbreads Recalled for Incorrect Milk Labeling

    Kracker Enterprises is recalling Doctor Kracker Klassic 3 Seed Crispbreads because the packaging lists milk as an ingredient, even though the product does not contain milk.

    Product
    Doctor Kracker Klassic 3 Seed Crispbreads Net Wt 7 oz (200g) in cardboard container.
    Category
    Food
    Distribution
    10 states