The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

4251–4275 of 21589

  • ModerateFDA (Devices)·Z-1627-2022·2022-08-31

    Medical device swab recall: Fisherbrand SWAB TRANS STUARTS

    Mckesson Medical-Surgical initiated a voluntary nationwide recall of Fisherbrand SWAB TRANS STUARTS swabs. The specific reason for the recall is not documented in the FDA notice.

    Product
    FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1446-2022·2022-08-31

    Excedrin Migraine Caplets Recalled Due to Improper Storage Conditions

    Family Dollar Stores is recalling Excedrin Migraine Caplets (24 CT) due to improper storage temperature conditions that may affect product quality. Affected products were distributed nationwide between April 30 and June 10, 2022.

    Product
    EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2022·2022-08-31

    Dynarex Lemon Glycerin Swabs recalled due to temperature exposure

    Dynarex lemon glycerin swabs distributed nationwide may have reduced effectiveness due to temperature excursions prior to delivery. All lots received between June 1 and September 30, 2021 are affected.

    Product
    Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1380-2022·2022-08-31

    Orajel Cold Sore Pain Cream Recalled for Improper Storage Conditions

    Orajel Cold Sore Pain Cream 1.25 fl. oz. was recalled because it was stored outside appropriate temperature conditions. The product was distributed to Family Dollar Stores from April 30 through June 10, 2022.

    Product
    Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1399-2022·2022-08-31

    Cough Drops Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling Vicks VapoCool Drops and Best Health Honey Lemon Cough Drops due to CGMP deviations involving improper storage temperature conditions. No illnesses have been reported.

    Product
    VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH DROP 80 CT SKU 998844 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1439-2022·2022-08-31

    MIDOL and Related OTC Menstrual Relief Products Recalled for Temperature Storage Deviation

    Family Dollar Stores recalled MIDOL COMPLETE, QP MENSTRUAL RELIEF, and QP PMS FORMULA caplets distributed April–June 2022 due to CGMP deviations from improper storage temperature.

    Product
    MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET 16CT SKU 999982 QP PMS FORMULA CAPLET 32 CT SKU 913232 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1616-2022·2022-08-31

    B. Braun Anesthesia Support Tray Temperature Excursion Recall

    B. Braun Medical Inc. is recalling Anesthesia Support Trays distributed between June and September 2021 due to temperature excursions during storage that may have affected product effectiveness.

    Product
    B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1368-2022·2022-08-31

    Multiple Mouthwash Products Recalled Due to Storage Temperature Deviations

    Family Dollar Stores is recalling multiple mouthwash brands sold between April and June 2022 because they were stored at improper temperatures. This storage deviation may compromise product quality and effectiveness.

    Product
    Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2022·2022-08-31

    Drugs of Abuse Test Kits Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling multiple brands of drugs of abuse test kits because temperature excursions prior to delivery may have reduced product effectiveness.

    Product
    Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2022·2022-08-31

    Lidocaine arthritis topical product recalled due to improper storage

    Family Dollar Stores is recalling Lidocaine Arthritis and Sport wintergreen liniment (16 fl oz, SKU 902929) distributed nationwide April 30–June 10, 2022, due to improper storage temperature conditions.

    Product
    LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1427-2022·2022-08-31

    Dulcolax 5 mg Tablets Recalled for Improper Storage Conditions

    Dulcolax 5 mg tablets distributed to Family Dollar Stores between April 30 and June 10, 2022 are recalled because they were stored outside appropriate temperature conditions, which could affect product effectiveness.

    Product
    DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1441-2022·2022-08-31

    Family Dollar Stye Eye Ointment Recalled Due to Improper Storage

    Family Dollar is recalling Stye Eye Ointment 0.125 oz due to manufacturing deviations. The product was held outside appropriate storage temperature conditions.

    Product
    STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1434-2022·2022-08-31

    Voltaren Arthritis Pain Gel Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Voltaren Arthritis Pain Gel 20G distributed April–June 2022 due to storage temperature deviations that may affect product effectiveness.

    Product
    VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1385-2022·2022-08-31

    Benadryl Extra Strength Cream Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Benadryl Extra Strength Cream 1 oz distributed from April 30 through June 10, 2022, because the product was held outside appropriate storage temperature conditions. No illnesses have been reported.

    Product
    BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2022·2022-08-31

    Cooper Surgical Milex Pessary Recalled for Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling Cooper Surgical Milex Pessary Ring products stored at elevated temperatures from June through August 2021, which may have degraded product effectiveness.

    Product
    COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2022·2022-08-31

    Fischer Cone Biopsy Excisor recalled for potential temperature damage

    McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.

    Product
    Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2022·2022-08-31

    NPX Enema 4.5 FL OZ Two-Pack Recalled for Improper Storage

    Family Dollar Stores is recalling NPX Enema 4.5 FL OZ 2-packs due to improper storage conditions that violate manufacturing standards. The product was held outside appropriate temperature conditions at select Family Dollar stores between April 30 and June 10, 2022.

    Product
    NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1407-2022·2022-08-31

    Good Sense Hemorrhoid Products Recalled for Improper Storage Conditions

    Good Sense Hemorrhoid Ointment and Wipes sold at Family Dollar stores from April through June 2022 are being recalled due to storage outside appropriate temperature conditions. No illnesses have been reported.

    Product
    GOOD SENSE HEMORRHOID OINTMENT 2 OZ SKU 910325 GOOD SENSE HEMORRHOIDAL WIPES 48 CT SKU 902260 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2022·2022-08-31

    Stryker SWANSON Finger Joint Implant Incorrect Sizing Label on Carton

    Wright Medical Technology is recalling 17 Stryker SWANSON Finger Joint Implants (size 00) due to incorrect sizing labels applied to carton packaging. Devices with lot numbers 1728375 and 1728376 were distributed across multiple US states and internationally.

    Product
    Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1414-2022·2022-08-31

    Guardian Antacid Products Recalled Due to Improper Storage Conditions

    Family Dollar's Guardian Antacid products were held outside appropriate storage temperatures, prompting an FDA Class II recall. Consumers should stop using affected products.

    Product
    GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION 60CT SKU 999845 GS EFFERVESCENT ANTACID TABLET 36 CT SKU 913102 GUARDIAN ANTCD TBLT XTRA STGTH BRY 96 CT SKU 914109 GUARDIAN ANTCID TBLT REG STTH FRT 150 CT SKU 914726 GC ANTACID SU
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2022·2022-08-31

    Strep A Test Kits Recalled for Potential Temperature Damage

    Multiple Strep A diagnostic test kits are being recalled due to temperature exposure during manufacturing and storage that may have compromised test accuracy. All lots received between June 1 and September 30, 2021 are affected.

    Product
    Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1392-2022·2022-08-31

    Pain Reliever Caplets Recalled for Improper Storage Temperature

    Over-the-counter pain reliever caplet products from Family Dollar stores are being recalled because they were stored outside proper temperature conditions.

    Product
    READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP 500MG CAPLET 250CT SKU 902332 READY IN CASE PM PAIN RELIEVER CAPLET 50 CT SKU 913982 GOOD SENSE PAIN RELIEVER APAP ES 500 CT SKU 999029 GOOD SENSE PAIN RELIEVER CAPLET 100 CT SKU 913890
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2022·2022-08-31

    SteriSpine PS surgical screws recalled for patient label mislabeling

    FDA recalls 8 SteriSpine PS multi-axial fenestrated screw kits distributed in Maryland due to incorrect labeling on patient documentation. The patient labels list the wrong screw type, though other labeling and the devices themselves are correct.

    Product
    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1377-2022·2022-08-31

    Dial Men's Eucalyptus Body Wash Recalled Due to Storage Temperature Deviation

    Family Dollar Stores is recalling Dial Men's Eucalyptus Body Wash 20 fl oz due to improper storage temperature conditions during distribution.

    Product
    DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2022·2022-08-31

    Mizuho OSI Femoral Hooks Recalled for Incorrect Model Etching

    Mizuho OSI is recalling one batch of regular femoral hooks that were etched with an incorrect model designation. The recalled batch contains 13 devices distributed in the United States and Canada.

    Product
    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
    Category
    Medical Device
    Distribution
    Distributed nationwide