The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

1351–1375 of 2769

  • LowFDA (Food)·F-1633-2017·2017-03-29

    Jugos La Morovena Grape Juice Recalled for Missing Phenylketonuria Warning

    Jugos y Agua La Morovena Inc. is recalling 106 gallons of grape juice in Puerto Rico because the labels lack the required phenylketonuria warning.

    Product
    Jugos La Morove¿a, Uva (Grape),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1632-2017·2017-03-29

    Jugos La Morovena Grapefruit Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 195 gallons of grapefruit juice in Puerto Rico because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Toronja (Grapefruit),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1639-2017·2017-03-29

    Jugos La Morovena Tamarind Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling Tamarind Juice in Puerto Rico because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Tamarindo (Tamarind) ,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1636-2017·2017-03-29

    Jugos La Morovena Passion Fruit Juice Recalled for Missing Label Warning

    Jugos y Agua La Morovena Inc. is recalling 150 gallons of Passion Fruit Juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Parcha (Passion Fruit),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1635-2017·2017-03-29

    Jugos La Morovena Soursop Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 95 gallons of Soursop juice in Puerto Rico because the labels lack the required phenylalanine warning for people with phenylketonuria.

    Product
    Jugos La Morove¿a, Guanabana (Soursop),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0608-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension due to failed dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1637-2017·2017-03-29

    Jugos La Morovena Acerola Cherry Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling Acerola Cherry Juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Acerola (Cherry), Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0609-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1439-2017·2017-03-22

    Smiths Medical Recalls CADD Solis VIP Pumps for Mistranslated Message

    Smiths Medical ASD, Inc. is recalling 20 CADD Solis VIP Ambulatory Infusion Pumps sold in Finland due to a mistranslated error message. The pump's function is unchanged, and no patient injury can occur.

    Product
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0521-2017·2017-03-22

    PreviDent Toothpaste Recalled for Incorrect Rear Panel Labeling

    Colgate is recalling 14,656 bottles of PreviDent 5000 toothpaste because the rear panel is incorrectly labeled with text from a different product.

    Product
    PREVIDENT — PREVIDENT (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2017·2017-03-22

    Pfizer Recalls PROTONIX IV Vials for Subpotent Potency

    Pfizer is recalling 582,165 vials of PROTONIX IV (pantoprazole sodium) because the drug failed potency testing at the 6-month stability time point.

    Product
    PROTONIX — PROTONIX (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0519-2017·2017-03-22

    G&W Laboratories Recalls Clindamycin Phosphate Topical Solution Due to Expired Ingredient

    G&W Laboratories is recalling specific lots of Clindamycin Phosphate Topical Solution because an expired active ingredient was used during manufacturing.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavi
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0603-2017·2017-03-22

    Pharmedium Recalls Buffered Lidocaine Syringes Due to Labeling Error

    Pharmedium Services, LLC is recalling 3,879 syringes of Buffered Lidocaine because the outer packaging is incorrectly labeled as 1% instead of 0.9%.

    Product
    Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1454-2017·2017-03-22

    Bencox Mirabo PE Liner Recalled for Incorrect Instruction Manual

    Corentec Co., Ltd. is recalling five units of Bencox Mirabo PE Liners distributed in Pennsylvania because they may contain Chinese instructions instead of US instructions.

    Product
    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1410-2017·2017-03-15

    Integra UNI-CP System Recalled for Incorrect Labeling

    Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System due to incorrect labeling on the plate.

    Product
    The UNI-CP System; Model Number: 330230SND.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1423-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.

    Product
    Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1416-2017·2017-03-15

    US Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch

    US Endoscopy Group Inc is recalling Roth Net Polyp Retrieval devices because the expiration date on the outer carton is shorter than the date on the inner package.

    Product
    Roth Net Polyp Retrieval
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-0788-2017·2017-03-08

    Medtronic SynchroMed II Software Card Recall for Priming Bolus Function

    Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.

    Product
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0504-2017·2017-03-08

    Perrigo Recalls Salicylic Acid Cream Due to Organic Impurity

    L. Perrigo Company is recalling Salicylic Acid Cream, 6%, due to an out-of-specification organic impurity. The FDA classified this as a Class III recall.

    Product
    Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0503-2017·2017-03-08

    Perrigo Recalls Salicylic Acid Shampoo Due to Organic Impurity

    L. Perrigo Company is recalling Salicylic Acid Shampoo, 6%, because the active ingredient failed impurity specifications.

    Product
    Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0509-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The recall covers 4,404 cartons distributed nationwide.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·022-2017·2017-03-06

    Rochester Meat Company Recalls Pork Sausage Products Due To Misbranding

    Rochester Meat Company is recalling approximately 13,330 pounds of pork sausage products because they contain undeclared monosodium glutamate (MSG). The products were shipped to institutional locations in five states.

    Product
    Branding Iron Holdings — Rochester Meat Company Recalls Pork Sausage Products Due To Misbranding
    Category
    Food
    Distribution
    5 states
  • LowUSDA FSIS·021-2017·2017-03-06

    F.B. Packing Co. Recalls Shaved Beef Products Due to Plastic Contamination

    F.B. Packing Co. is recalling approximately 8,430 pounds of shaved beef products that may contain plastic strands. The recall covers products shipped to retail locations in Illinois and Massachusetts.

    Product
    Bertolino Foods, Inc. — F.B. Packing Co., Inc. Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1238-2017·2017-03-01

    Hidrex Recalls Daavlin Aquex Devices Due to Documentation Requirements

    Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Daavlin Aquex (DAAV1000)
    Category
    Medical Device
    Distribution
    Distributed nationwide