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.

226–250 of 261

  • 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-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-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 (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 (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-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 (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-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-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-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
  • LowFDA (Food)·F-0929-2021·2021-09-08

    Frozen Cheesecake and Torte Products Mislabeled with Incorrect Ingredients

    Gem City Fine Foods is recalling frozen desserts with mismatched ingredient and nutrition labels, and with false pecan labeling despite no nuts being used since April 2018.

    Product
    Triple Berry Streusel Cheesecake, 20 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001193. Store Frozen or Thawed in Fridge.
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-2363-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates

    Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2374-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0785-2021·2021-09-08

    Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications

    Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.

    Product
    Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0784-2021·2021-09-08

    Donepezil HCL Tablets 5 mg Recalled for Subpotency

    Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.

    Product
    Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2375-2021·2021-09-08

    Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions

    Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0771-2021·2021-09-01

    Bleomycin for Injection Recalled Due to Mislabeling

    Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0870-2021·2021-08-25

    Cotton Blues Cheesecake Strawberry Swirl recalled for incorrect ingredient labeling

    CB Distribution LLC is recalling Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice packages due to incorrect ingredient labeling. The product was distributed to distribution centers in Texas.

    Product
    Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice 6oz plastic container 36 packages per case
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-0859-2021·2021-08-18

    Wickles Relish 16oz Glass Jars Recalled for Wrong Label

    Magnolia Vegetable Processors is recalling Wickles Relish 16oz glass jars (Lot No. 2001210406) due to an incorrect label applied to the product. The affected cases were distributed to eight states.

    Product
    Wickles Relish 16oz glass jars - 6 jars per case
    Category
    Food
    Distribution
    8 states