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.

476–500 of 2766

  • LowFDA (Drugs)·D-1541-2020·2020-09-02

    Red Cross Oral Pain Relief Recalled for Cotton Pellet Labeling Error

    The Mentholatum Company is recalling Red Cross Oral Pain Relief blister packs because the included cotton pellet box incorrectly lists Natural Eugenol Oil as an ingredient.

    Product
    RED CROSS ORAL PAIN RELIEF — RED CROSS ORAL PAIN RELIEF (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1166-2020·2020-08-26

    La Canasta Recalls My Nana's Tortilla Chips for Staleness

    La Canasta Mexican Food Products is recalling My Nana's Thick & Crunchy Tortilla Chips because they turn stale before the expiration date.

    Product
    My Nana's Thick & Crunchy Tortilla Chips, 12 oz. (340g) paper bag (12 bags per case), UPC 0-34392-10161-8.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-1513-2020·2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1512-2020·2020-08-26

    Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

    Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

    Product
    Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1497-2020·2020-08-19

    Golden State Medical Supply Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure

    Golden State Medical Supply Inc. is recalling specific lots of Clobetasol Propionate Cream, USP, 0.05% because the bulk material failed content uniformity testing.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2781-2020·2020-08-19

    Linet AVE 2 Birthing Bed Recalled for Incorrect Manufacturer Labeling

    Linet Americas is recalling 202 AVE 2 Birthing Beds because the Unique Device Identifier (UDI) on the label indicates the incorrect manufacturer.

    Product
    AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1143-2020·2020-08-12

    Vitamin Shoppe Recalls Calcium Citrate Plus Magnesium & Vitamin D Supplements

    Vitamin Shoppe is recalling specific bottles of Calcium Citrate Plus Magnesium & Vitamin D because sample analysis revealed the product is sub-potent for Vitamin D.

    Product
    The Vitamin Shoppe Calcium Citrate Plus Magnesium & Vitamin D. 100 count (VS-1086; UPC:6653601086), 300 count (VS-1087; UPC: 6653601087), and 600 count (VS-1123; UPC: 6653601123).
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1410-2020·2020-08-05

    Allergan Recalls Skin Medica Acne System Kits for Subpotency

    Allergan is recalling 8,555 Skin Medica Acne System kits nationwide because the products failed potency tests at 12 and 24 months.

    Product
    Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2642-2020·2020-07-29

    LivaNova Recalls Sterile Disposable Connectors Due to Incorrect Reducer Parts

    LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.

    Product
    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1392-2020·2020-07-29

    HF Acquisition Recalls Famotidine Injection Due to Temperature Abuse

    HF Acquisition Co. LLC is recalling specific lots of Famotidine Injection because a customer reported the product was received in a non-refrigerated state.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1391-2020·2020-07-22

    Fresenius Kabi Recalls Fosaprepitant Injection Due to Labeling Error

    Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2550-2020·2020-07-22

    Access Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits

    Access Scientific LLC is recalling 1,710 Powerwand XL kits due to incorrect catheter length labels. The error may cause treatment delays or user annoyance.

    Product
    POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1381-2020·2020-07-15

    Biogen Recalls Tecfidera Capsules Due to Quality Control Deviations

    Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.

    Product
    TECFIDERA — TECFIDERA (DIMETHYL FUMARATE)
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-1374-2020·2020-07-15

    Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution

    Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1377-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

    VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1378-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

    VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1375-2020·2020-07-15

    Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution

    Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1018-2020·2020-07-01

    Stumptown Cold Brew Coffee Recalled for Packaging Leakage

    Stumptown Coffee Corp is recalling 900 units of Cold Brew Coffee and Chocolate with Oatmilk due to packaging failure causing leakage.

    Product
    Stumptown Cold Brew Coffee and Chocolate with Oatmilk. Product is TetraPak Prisma Pak aseptic packaging. Keep refrigerated. Net 11 fl. oz (325 mL). UPC on the single unit is 8 55186 00688 5.
    Category
    Food
    Distribution
    8 states
  • LowFDA (Drugs)·D-1372-2020·2020-07-01

    Nabumetone Tablets Recalled for Missing Medication Guide Labeling

    American Health Packaging is recalling 265 cartons of Nabumetone Tablets because the carton label did not include the required statement to dispense with the accompanying Medication Guide.

    Product
    Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1342-2020·2020-07-01

    Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications

    Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.

    Product
    Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2407-2020·2020-07-01

    Utak Trace Elements Serum Control Recalled for Incorrect Reference Values

    Utak Laboratories is recalling 1,395 vials of NR Trace Elements Serum Control due to incorrect cadmium reference values and expected ranges.

    Product
    Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide