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.

15326–15350 of 21645

  • ModerateFDA (Drugs)·D-0591-2016·2016-02-03

    Pharmakon Recalls Rocuronium Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 5,875 units of Rocuronium 10 mg/mL syringes because stability data does not support the expiration dates.

    Product
    Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0590-2016·2016-02-03

    Pharmakon Recalls Phenylephrine Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Phenylephrine injectable syringes because stability data does not support the expiration dates.

    Product
    Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 525 syringes of Morphine Sulfate because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0605-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 378 units of Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers lots expiring up to November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·16V059000·2016-02-03

    Forest River Recalls 2016 Wildcat Trailers for Incorrect Weight Placards

    Forest River is recalling 52 model year 2016 Wildcat recreational trailers because they may have incorrect Federal placards with a reduced Gross Axle Weight Rating.

    Product
    FOREST RIVER — FOREST RIVER WILDCAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2016·2016-02-03

    Pharmakon Recalls Glycopyrrolate Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 1,530 syringes of Glycopyrrolate 0.2 mg/mL because stability data does not support the expiration dates.

    Product
    Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2016·2016-02-03

    Amerisource Recalls Levofloxacin Tablets Due to Dissolution Failures

    Amerisource Health Services is recalling 3,888 cartons of Levofloxacin 500 mg tablets because they failed dissolution specifications.

    Product
    Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2016·2016-02-03

    Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL because stability data does not support the expiration dates.

    Product
    Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0594-2016·2016-02-03

    Pharmakon Recalls Ondansetron Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 4,100 units of Ondansetron 2 mg/mL injectable syringes because stability data does not support the expiration dates.

    Product
    Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0588-2016·2016-02-03

    Pharmakon Recalls Ephedrine Sulfate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL injectable syringes because stability data does not support the expiration dates.

    Product
    Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0595-2016·2016-02-03

    Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 665 syringes of Midazolam (PF) because stability data does not support the expiration dates. The recall is nationwide.

    Product
    Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2016·2016-02-03

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because stability data does not support the expiration dates. The recall covers 7,100 units distributed nationwide.

    Product
    Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0697-2016·2016-02-03

    Phadia Recalls EliA SmDP Wells Due to Invalid Test Results

    Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.

    Product
    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2016·2016-02-03

    Perrigo Recalls Children's Guaifenesin DM Liquid Due to Dosing Cup Errors

    Perrigo is recalling specific lots of Children's Guaifenesin DM Cherry liquid because the included dosing cups have incorrect dose markings.

    Product
    Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0606-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. All lots expiring up to 11/17/2015 are affected.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2016·2016-02-03

    Pharmakon Recalls Lidocaine HCI Injectable Syringes Due to Stability Data

    Pharmakon Pharmaceuticals is recalling Lidocaine HCI 2% injectable syringes because stability data does not support the expiration dates.

    Product
    Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2016·2016-02-03

    Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL because stability data does not support the expiration dates.

    Product
    Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0586-2016·2016-02-03

    Perrigo Recalls Guaifenesin Liquid Due to Incorrect Dosing Cup Markings

    Perrigo Company PLC is recalling specific lots of Guaifenesin liquid because the included dosing cups have incorrect dose markings.

    Product
    Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0597-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0600-2016·2016-02-03

    Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data

    Pharmakon Pharmaceuticals is recalling 600 syringes of Ketamine 100 mg/mL because stability data does not support the expiration dates.

    Product
    Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2016·2016-01-27

    Arkray SPOTCHEM II Reagent Test Strips Recalled for Glucose Error

    Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.

    Product
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0578-2016·2016-01-27

    Grato Holdings Recalls Energique Shingles Pain Spray Due to Microbial Contamination

    Grato Holdings is recalling Energique Shingles Pain & Ulceration Relief Topical Spray due to out-of-specification microbial counts. The recall covers 371 bottles distributed nationwide and to Guatemala and Canada.

    Product
    Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2016·2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 45 units of FMS neXtra 3.5mm Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0571-2016·2016-01-27

    Morton Grove Recalls Lindane Lotion Due to Out-of-Specification Assay

    Morton Grove Pharmaceuticals is recalling specific lots of Lindane Lotion because stability samples failed assay testing. Consumers should stop using the product and return it to their pharmacy.

    Product
    Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
    Category
    Drug
    Distribution
    Distributed nationwide