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.

401–425 of 2738

  • LowFDA (Food)·F-0332-2021·2021-03-17

    One Degree Organic Foods Recalls Gluten Free Sprouted Rolled Oats

    One Degree Organic Foods is recalling 448,720 packages of Gluten Free Sprouted Rolled Oats due to rancidity and packaging integrity defects.

    Product
    One Degree Organic Foods Gluten Free Sprouted Rolled Oats NET WT. 5 lbs (80 oz) 2.27 kg UPC:6 75625 32318 8
    Category
    Food
    Distribution
    11 states
  • LowFDA (Devices)·Z-1183-2021·2021-03-17

    OraSure Methamphetamine Test Kit Recalled for Incorrect Reagent Lot Labeling

    OraSure Technologies is recalling 16 units of Methamphetamine Intercept Microplate kits due to a labeling error where the wrong lot number was printed on the box.

    Product
    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0289-2021·2021-03-10

    Sun Pharma Recalls Subpotent Cequa Cyclosporine Ophthalmic Solution Vials

    Sun Pharmaceutical Industries is recalling Lot 10007 of Cequa (cyclosporine) ophthalmic solution because the product is subpotent. The recall covers 37,400 cartons distributed nationwide and in Australia.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0298-2021·2021-03-10

    Jubilant Cadista Recalls Methylprednisolone Tablets Due to Illegible Labeling

    Jubilant Cadista Pharmaceuticals is recalling specific lots of Methylprednisolone Tablets USP, 4 MG, due to misaligned printing on the blister card that makes dosing instructions illegible.

    Product
    Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0336-2021·2021-03-10

    Ferrara Candy Company Recalls Assorted Candy Heart Box for Undeclared Ingredients

    Ferrara Candy Company is recalling assorted candy Heart Boxes containing Laffy Taffy, Nerds, and SweeTarts due to undeclared ingredients on the retail packaging.

    Product
    Ferrara Candy Company assorted candy Heart Box, including Laffy Taffy, Nerds, and SweeTarts candies. 10 retail units per wholesale case. Package UPC 0 41420 04965 1
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1168-2021·2021-03-10

    Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals

    Boston Scientific is recalling Captivator and Captiflex polypectomy snares because users reported incomplete pouch seals before patient use.

    Product
    Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1169-2021·2021-03-10

    Boston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals

    Boston Scientific is recalling Captivator II Single-Use Polypectomy Snares because users reported incomplete pouch seals before use.

    Product
    Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0291-2021·2021-03-10

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they contain impurities that exceed FDA specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0319-2021·2021-03-03

    House Autry Tartar Sauce Recalled Due to Spoilage Complaints

    House-Autry Mills is recalling 9-ounce bottles of tartar sauce after a consumer reported the product was spoiled.

    Product
    HOUSE AUTRY TARTAR SAUCE NET WT 9 OZ (255g) DISTSRIBUTED BY House -Autry Mills, Inc. Four Oaks, NC 27524 UPC 0 73484 60013 4
    Category
    Food
    Distribution
    6 states
  • LowFDA (Devices)·Z-1135-2021·2021-03-03

    Medline Recalls STAT-Site B-HB Controls Due to Shipment Compromise

    Medline Industries is recalling specific lots of STAT-Site B-HB controls because the products were compromised during shipment. The recall affects 46 units distributed in Mississippi, Ohio, and Illinois.

    Product
    S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0250-2021·2021-02-17

    Accord Recalls Glycopyrrolate Injection Due to Labeling Mix-up

    Accord Healthcare is recalling 502 cartons of Glycopyrrolate Injection due to a packaging error where 2 mL vials were placed in 1 mL blister strips.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0940-2021·2021-02-10

    Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion

    Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.

    Product
    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number…
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Drugs)·D-0247-2021·2021-02-10

    Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues

    Lupin Pharmaceuticals is recalling 46,479 bottles of Oseltamivir Phosphate oral suspension because out-of-specification test results were found for Impurity C during stability testing.

    Product
    OSELTAMIVIR PHOSPHATE — OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2021·2021-02-03

    Bausch Health Recalls Mephyton Tablets Due to Impurity D Failure

    Bausch Health is recalling 895 bottles of Mephyton (phytonadione) 5mg tablets because Impurity D failed stability testing specifications.

    Product
    Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2021·2021-02-03

    Bausch Health Recalls Phytonadione Tablets Due to Impurity D

    Bausch Health is recalling Phytonadione Tablets 5mg because Impurity D exceeded specifications during stability testing. The recall covers 14,089 bottles distributed nationwide.

    Product
    Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0224-2021·2021-01-20

    KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity

    KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.

    Product
    Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0223-2021·2021-01-20

    US Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error

    US Compounding Inc is recalling 1,534 syringes of Succinylcholine Chloride Injection because the lot number and expiration date were printed in the wrong position, making them illegible.

    Product
    Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0795-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration Defect

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0787-2021·2021-01-13

    Steris Vis-U-All High Temperature Tubing Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0799-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration on Exterior Labels

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects or ink transfer to devices.

    Product
    Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0794-2021·2021-01-13

    Steris Vis-U-All Pouches Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.

    Product
    Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0797-2021·2021-01-13

    Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

    Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0791-2021·2021-01-13

    Steris Vis-U-All Heat Seal Pouches Recalled for Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing.

    Product
    Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
    Category
    Medical Device
    Distribution
    Distributed nationwide