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.

301–325 of 2766

  • LowFDA (Drugs)·D-0367-2022·2022-01-19

    Morphine Sulfate Oral Solution 20 mg/mL recalled for missing label

    Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.

    Product
    Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0467-2022·2022-01-19

    Ki Mobility Little Wave Tyke Manual Contains Incorrect Instructions

    The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.

    Product
    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by per
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Food)·F-0283-2022·2021-12-22

    The Mustard Man Inc Simply Peppered Mustard Wrong Product Packaging

    The Mustard Man Inc is recalling Simply Peppered Mustard bottles that were incorrectly filled with Simply Horsey Mustard instead. The product was distributed in eight states and should not be consumed.

    Product
    The Mustard Man Inc Simply Peppered Mustard 8oz plastic bottles, 6 bottles per case
    Category
    Food
    Distribution
    8 states
  • LowFDA (Food)·F-0334-2022·2021-12-22

    Morton Iodized Salt Lacks Required Iodine Fortification

    Morton Iodized Salt labeled as iodized actually contains salt without iodine fortification. The recall affects 16,920 canisters distributed to retailers in Colorado and California.

    Product
    Morton Iodized Salt, Net Wt. 26 oz (1 LB 10 OZ) 737 g, Morton Salt, Inc. Chicago, IL 60606
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0275-2022·2021-12-15

    Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0272-2022·2021-12-15

    Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.

    Product
    12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0273-2022·2021-12-15

    CVS Allergy Relief D Extended-Release Tablets Recall

    CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0268-2022·2021-12-15

    CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.

    Product
    Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0316-2022·2021-12-08

    INBONE Total Ankle System Recalled Due to Package Labeling Mismatch

    Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.

    Product
    INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0264-2022·2021-12-08

    Tydemy Oral Contraceptive Recalled Due to Subpotent Drug

    Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.

    Product
    Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0256-2022·2021-12-01

    Butalbital/APAP/Caf Tablets Missing Controlled Substance Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, and Caffeine 50/325/40 mg tablets because the label is missing the controlled substance classification "CIII" required by law.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0257-2022·2021-12-01

    Butalbital, APAP, Caffeine Tablets Missing Schedule III Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, Caffeine 50/325/40 mg tablets in multiple bottle sizes because the controlled substance classification "CIII" is missing from the label.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0255-2022·2021-12-01

    Topiramate 50 mg tablets recalled due to discoloration

    Unichem Pharmaceuticals USA Inc is recalling Topiramate 50 mg tablets nationwide due to discoloration. The affected lot is ZTPM20044, expiring 09/30/2022.

    Product
    TOPIRAMATE — TOPIRAMATE (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0263-2022·2021-12-01

    Carvedilol Tablets Recalled for Failed Impurities and Degradation Specifications

    Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0213-2022·2021-12-01

    Mexican Side Salad Recalled for Potential Plastic Fragment Contamination

    Ukrop's Homestyle Foods, LLC is recalling Mexican Side Salad 6.95oz. containers due to potential contamination with plastic fragments. Affected products were distributed to retail and distribution centers in six states.

    Product
    Mexican Side Salad 6.95oz. (197g). Packaged in plastic containers.
    Category
    Food
    Distribution
    6 states
  • LowFDA (Devices)·Z-0247-2022·2021-11-24

    VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information

    Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.

    Product
    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
    Category
    Medical Device
    Distribution
    19 states
  • LowFDA (Drugs)·D-0096-2022·2021-11-17

    Cetirizine Hydrochloride 10 mg Tablets Labeling Error Recall

    A-S Medication Solutions LLC is recalling Cetirizine hydrochloride 10 mg tablets due to a labeling error: bottles were labeled as 90-count when they actually contain 30 tablets.

    Product
    CETIRIZINE — CETIRIZINE (CETIRIZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-0069-2022·2021-11-03

    Kirkland Signature AllerClear D 24 HR Tablets Recalled for Moisture Failure

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR (Loratadine and Pseudoephedrine Sulfate) tablets nationwide because the product failed to meet moisture content limits.

    Product
    KIRKLAND SIGNATURE ALLERCLEAR D 24 HR — KIRKLAND SIGNATURE ALLERCLEAR D 24 HR (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0072-2022·2021-11-03

    ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).

    Product
    ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shi
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0071-2022·2021-11-03

    Vica-Cet Back Pain Relief tablets recalled for stability specification failure

    Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.

    Product
    Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0006-2022·2021-10-13

    Mr. Nut Dried Oleaster Recalled for Undeclared Sulfites

    Vintage Food Corp. is recalling Mr. Nut brand Dried Oleaster (10.6 OZ, expiration 10/2022, LOT#20-040) because the product contains undeclared sulfites, which may pose a health risk to sensitive consumers.

    Product
    Mr. Nut brand Dried Oleaster Net Wt: 10.6 OZ (300g). Expiration date 10/2022. UPC 0360894900.
    Category
    Food
    Distribution
    17 states
  • LowFDA (Drugs)·D-0853-2021·2021-10-06

    CVS Health Daytime Cold & Flu Relief Drug Recalled for Subpotency

    CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials are being recalled because the product is subpotent—containing less active ingredient than intended. The recall affects specific lot numbers distributed across 14 U.S. states.

    Product
    CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
    Category
    Drug
    Distribution
    14 states
  • LowFDA (Food)·F-0017-2022·2021-10-06

    Dairy Free Co. Dollup Lama Cashew Topping Recalled for Off Taste

    Central Kitchen Food Hub is recalling Dairy Free Co. Dollup Lama Sour & Creamy Cashew Topping due to quality concerns involving an off taste. The recall affects 155 cases distributed to California, Arizona, Pennsylvania, Indiana, and Ohio.

    Product
    Dairy Free Co. Dollup Lama Sour & Creamy Cashew Topping 4oz, 6 containers per case
    Category
    Food
    Distribution
    5 states
  • LowFDA (Drugs)·D-0798-2021·2021-09-22

    Candesartan Cilexetil tablets recalled for impurity specification failure

    Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg due to failed impurities and degradation specifications. One lot distributed nationwide does not meet required purity standards.

    Product
    CANDESARTAN CILEXETIL — CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
    Category
    Drug
    Distribution
    Distributed nationwide