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.

12626–12650 of 21617

  • ModerateFDA (Food)·F-2281-2017·2017-06-07

    Trident Alaska Cod Rectangles Recalled for Potential Plastic Contamination

    Trident Seafoods is recalling frozen Alaska Cod Rectangles because they may contain small pieces of plastic. The product was distributed in 26 states.

    Product
    Trident Item # 16582, Alaska Cod Rectangles 4 oz, Raw Breaded, food service packages, frozen, Net wt. 10 lbs.
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Drugs)·D-0880-2017·2017-06-07

    Saphris Asenapine Tablets Recalled for Labeling Mixup

    Forest Laboratories is recalling Saphris (asenapine) sublingual tablets because blister packs labeled as 10 mg actually contain 5 mg tablets.

    Product
    SAPHRIS — SAPHRIS (ASENAPINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2017·2017-06-07

    Invacare Assist Bed Rail 6632 Recalled for Manual Typo

    Invacare is recalling 5,020 Assist Bed Rail 6632 units because a typo in the user manual could lead to incorrect installation.

    Product
    Assist Bed Rail - 6632
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2170-2017·2017-06-07

    Arrow VPS Access Kit Recalled for Missing Dressing Information

    Arrow International is recalling VPS Access Kits because they lack required information regarding the included 3M Tegaderm CHG dressing.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0824-2017·2017-05-31

    Advanced Pharma Recalls Diltiazem HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all Diltiazem HCl products because they may contain latex but lack proper labeling.

    Product
    Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2017·2017-05-31

    Advanced Pharma Recalls Ropi Epi Clon Injection Due to Latex Labeling

    Advanced Pharma Inc. is recalling Ropi/ Epi/ Clon PeriCapsular injection because the product may contain latex and lacks appropriate labeling.

    Product
    Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0866-2017·2017-05-31

    Gentell Recalls Moisture Barrier Cream Due to Manufacturing Deviations

    Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream because it may not meet cGMP requirements.

    Product
    Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0846-2017·2017-05-31

    Advanced Pharma Recalls Dexmedetomidine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Dexmedetomidine HCl because the product may contain synthetic or natural latex, which is not currently labeled.

    Product
    Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0821-2017·2017-05-31

    Advanced Pharma Recalls Oxytocin Due to Potential Latex Content

    Advanced Pharma Inc. is recalling all Oxytocin products due to a labeling issue regarding potential synthetic or natural latex content.

    Product
    Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0805-2017·2017-05-31

    Advanced Pharma Recalls Early TPN Neonatal Products for Latex Labeling

    Advanced Pharma Inc. is recalling Early TPN (Neonatal) products nationwide due to a labeling error regarding potential latex content.

    Product
    Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2017·2017-05-31

    Advanced Pharma Recalls Cefazolin Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all lots of Cefazolin because the product may contain latex but lacks appropriate labeling.

    Product
    Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0845-2017·2017-05-31

    Advanced Pharma Recalls Dexamethasone Sodium Phosphate for Latex Labeling

    Advanced Pharma Inc. is recalling Dexamethasone Sodium Phosphate because the product may contain latex but lacks proper labeling.

    Product
    Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0804-2017·2017-05-31

    Advanced Pharma Recalls Standard Starter TPN Due to Latex Labeling

    Advanced Pharma Inc. is recalling Standard Starter TPN products because they may contain synthetic or natural latex without proper labeling.

    Product
    Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2017·2017-05-31

    Advanced Pharma Recalls Phenylephrine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Phenylephrine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0808-2017·2017-05-31

    Advanced Pharma Recalls Sufentanil Citrate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Sufentanil Citrate because the product may contain latex, which is not currently disclosed on the label.

    Product
    Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2017·2017-05-31

    Advanced Pharma Recalls Bumetanide Due to Latex Labeling Deficiency

    Advanced Pharma Inc. is recalling all strengths and dosage forms of Bumetanide because the product labeling fails to disclose that it may contain synthetic or natural latex.

    Product
    Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2017·2017-05-31

    Innovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving

    Innovasis, Inc. is recalling 21 Opteryx Variable Rescue Screws because they are engraved with an incorrect, larger size (16 instead of 14).

    Product
    Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2017·2017-05-31

    Advanced Pharma Recalls Famotidine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Famotidine HCl because the product may contain latex but lacks proper labeling.

    Product
    Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0803-2017·2017-05-31

    Advanced Pharma Recalls TPN Neonatal Due to Latex Labeling

    Advanced Pharma Inc. is recalling TPN Neonatal products because they may contain latex but lack proper labeling.

    Product
    TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2017·2017-05-31

    Magnesium Sulfate Recall for Potential Latex Content

    Advanced Pharma Inc. is recalling Magnesium Sulfate products due to potential latex content not clearly labeled.

    Product
    Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0834-2017·2017-05-31

    Advanced Pharma Recalls Nicardipine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling all lots of Nicardipine HCl because the product may contain latex but lacks appropriate labeling.

    Product
    Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2017·2017-05-31

    Advanced Pharma Recalls Amiodarone Due to Potential Latex Content

    Advanced Pharma Inc. is recalling all Amiodarone products due to a labeling issue regarding potential synthetic or natural latex content.

    Product
    Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2017·2017-05-31

    Advanced Pharma Recalls Fentanyl Citrate with Ropivacaine HCl Due to Latex Labeling

    Advanced Pharma Inc. is recalling Fentanyl Citrate with Ropivacaine HCl because the product may contain latex and lacks appropriate labeling.

    Product
    Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide