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 2738

  • LowFDA (Drugs)·D-0015-2021·2020-10-14

    Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities

    Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.

    Product
    Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0004-2021·2020-10-07

    Rite Aid Nicotine Gum Recalled for Incorrect Package Insert

    P & L Developments is recalling 4,752 cartons of Rite Aid 2 mg nicotine gum because the package insert is for the Canadian market and not the approved US labeling.

    Product
    Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1625-2020·2020-10-07

    Arbor Pharmaceuticals Recalls Subpotent Nymalize Oral Solution

    Arbor Pharmaceuticals is voluntarily recalling Nymalize (nimodipine) oral solution because the drug is subpotent. The FDA classifies this as a Class III recall.

    Product
    Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3001-2020·2020-09-30

    OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing

    OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.

    Product
    CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3002-2020·2020-09-30

    OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes

    OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.

    Product
    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3003-2020·2020-09-30

    OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes

    OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.

    Product
    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3004-2020·2020-09-30

    DNA Genotek PrepIT Q2A Kit Recalled for Expired Reagents

    DNA Genotek Inc. is recalling 74 units of the PrepIT Q2A Kit because reagents were shipped after their expiration dates.

    Product
    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2977-2020·2020-09-23

    Oxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error

    Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.

    Product
    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2957-2020·2020-09-23

    Maquet Rotaflow System Console Instructions for Use Recall

    Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.

    Product
    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1585-2020·2020-09-23

    Exela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill

    Exela Pharma Sciences LLC is voluntarily recalling 23,775 vials of Potassium Acetate Injection, USP due to short fill issues.

    Product
    Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2976-2020·2020-09-23

    Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates

    Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.

    Product
    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2948-2020·2020-09-16

    MicroPort Recalls PROFEMUR Modular Necks for Package Insert Update

    MicroPort Orthopedics is voluntarily recalling PROFEMUR Titanium and Cobalt Chrome modular necks to replace older package inserts with the most recent revision.

    Product
    PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2886-2020·2020-09-02

    Match Point System surgical instrument recalled due to incorrect procedure side labeling

    The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.

    Product
    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2877-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling

    OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2876-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling

    OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
    Category
    Medical Device
    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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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