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.

626–650 of 2738

  • LowFDA (Devices)·Z-0607-2020·2019-12-11

    Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark

    Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.

    Product
    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0187-2020·2019-12-04

    Great Lakes Cheese Recalls American Cheese Loaves Due to Metal Foreign Material

    Great Lakes Cheese Co Inc is recalling 2,487 cases of pasteurized process American cheese loaves because they may contain metal foreign material.

    Product
    Pasteurized Process American Cheese, white, 2 - 5lb loaves per case. Brands as follows: 1) ingles; 2) Publix Deli; 3) Primo Taglio Classics; 4) Tropical
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-0546-2020·2019-12-04

    Spineart JULIET Ti OL Cage Recalled for Incorrect Inner Blister Label

    Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.

    Product
    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0576-2020·2019-12-04

    Spectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton

    Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.

    Product
    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Drugs)·D-0522-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0190-2020·2019-12-04

    Great Value Old Fashioned Glazed Donuts Recalled for Packaging Glue

    United States Bakery Corp is recalling Great Value Old Fashioned Glazed Donuts because packaging glue was found inside the boxes.

    Product
    Great Value Old Fashioned Glazed Donuts packaged in a paperboard box with cellophane window and each box contains 6 donuts. Net Wt. per box: 12 oz. (340 g). UPC on retail box: 0 78742 30711 4. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. Each master case contains…
    Category
    Food
    Distribution
    6 states
  • LowFDA (Food)·F-0193-2020·2019-12-04

    Merical Recalls Leader Advanced Probiotic Due to Incorrect Labeling

    Merical, LLC is recalling Leader Advanced Probiotic capsules because the label lists the wrong probiotic blend. Consumers should stop using the product.

    Product
    Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0521-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0185-2020·2019-12-04

    Great Lakes Cheese Recalls American Cheese Loaves for Metal Foreign Material

    Great Lakes Cheese Co Inc is recalling 4,700 cases of pasteurized process American cheese loaves that may contain metal foreign material.

    Product
    Pasteurized Process American Cheese, yellow, 6 - 5lb loaves per case. Brands as follows: 1) Delicatessan Quality; 2) John F. Martin & Sons; 3) Best Yet; 4) Market 32; 5) Black Bear; 6) ShopRite
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-0493-2020·2019-11-27

    Hager & Meisinger Recalls Dental Carbide Burs Due to Packaging Error

    Hager & Meisinger is recalling 2,500 dental carbide burs because a 1.0 mm blade may have been packaged in 0.9 mm packaging.

    Product
    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-0519-2020·2019-11-27

    X-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert

    X-Gen Pharmaceuticals is recalling Levetiracetam Injection vials because the incorrect package insert version was attached to the product.

    Product
    Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0322-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Zentrip Meclizine Hydrochloride Strips

    Sato Pharmaceutical Inc. is voluntarily recalling Zentrip (meclizine Hydrochloride) 25 mg strips because the medication is subpotent. The recall covers 21,864 units distributed nationwide.

    Product
    Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0323-2020·2019-11-20

    CVS Motion Sickness Tablets Recalled for Subpotent Drug Levels

    Sato Pharmaceutical is recalling CVS Motion Sickness Fast Melting tablets because they may contain less than the labeled amount of meclizine hydrochloride.

    Product
    CVS MOTION SICKNESS FAST MELTING — CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0325-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide

    Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.

    Product
    Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0324-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Wal-Dram 2 Meclizine Hydrochloride Tablets

    Sato Pharmaceutical Inc. is voluntarily recalling specific lots of Wal-Dram 2 Quick-Dissolving tablets because they contain less than the labeled amount of meclizine hydrochloride.

    Product
    WAL-DRAM 2 QUICK-DISSOLVING — WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0297-2020·2019-11-13

    Helena Laboratories Recalls SPIFE Alkaline Hemoglobin Kits Due to Incorrect Instructions

    Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.

    Product
    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
    Category
    Medical Device
    Distribution
    22 states
  • LowFDA (Food)·F-0098-2020·2019-11-13

    La Samaritana Tomato Tortillas Recalled for Undeclared Red Dye

    Productos La Samaritana is recalling specific lots of tomato tortillas because they contain FD&C Red #40, which is not declared on the label.

    Product
    Selecto Wraps de Tomate, Tomato Wraps Econo Healthy Wraps, Soft Flour Tortillas, Tomate La Samaritana Tortillas, (Harina de Trigo) Tomate
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-0125-2020·2019-11-13

    Dr. Pepper 24-Pack Cans Recalled for Undeclared Aspartame

    Epic Enterprises is recalling Dr. Pepper 24-pack cans in Connecticut, Maine, and Rhode Island because they contain undeclared aspartame.

    Product
    Dr. Pepper 24 pack of 12 FL OZ Cans (288 FL OZ) in cardboard cases: Produced under the authority of Dr. Pepper/Seven Up, Inc., 5301 Legacy Drive, Plano, TX 75024; Best Before: JUN 29 20; Case UPC: 078000082104; Can UPC: 07831504
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0304-2020·2019-11-13

    Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance

    Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.

    Product
    Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0303-2020·2019-11-13

    Sato Pharmaceutical Recalls Sankaijo Botanical Laxative Tablets

    Sato Pharmaceutical Inc. is recalling Sankaijo Botanical Laxative tablets because the sennosides content is lower than the labeled claim.

    Product
    SANKAIJO — SANKAIJO (DOCUSATE SODIUM, SENNOSIDES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0099-2020·2019-11-13

    La Samaritana Tortillas Recalled for Failure to Declare FD&C Red #40

    Productos La Samaritana, Inc. is recalling specific lots of La Samaritana Tortillas because they contain FD&C Red #40, which was not declared on the label.

    Product
    La Samaritana Tortillas (Harina de Trigo) 8/12-12" Reg Rojo
    Category
    Food
    Distribution
    0 states