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.

2151–2175 of 3531

  • ModerateFDA (Drugs)·D-1472-2022·2022-09-07

    Nighttime Sleep-Aid tablets recalled due to carton labeling error

    CVS Pharmacy is recalling Nighttime Sleep-Aid tablets because the carton incorrectly identifies the active ingredient as doxylamine succinate HCl instead of doxylamine succinate. Approximately 257,064 cartons were distributed nationwide.

    Product
    Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1680-2022·2022-09-07

    Lemon Pickle Recalled Due to Undeclared Wheat Starch Allergen

    Yem Foods LLC is recalling Priyems Lemon Pickle due to undeclared wheat starch found in asafoetida, a spice ingredient. Consumers with wheat allergies or celiac disease should not consume affected products.

    Product
    Priyems Lemon Pickle 1lb/454g UPC 8 61754 000117, 10 retail units per wholesale case, Refrigerated
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1640-2022·2022-09-07

    bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies

    bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.

    Product
    VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1471-2022·2022-09-07

    Timolol Maleate eye drops recalled for unknown impurity in stability testing

    Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1467-2022·2022-09-07

    Colgate Anticavity Fluoride Toothpaste recalled for improper storage conditions

    Colgate Anticavity Fluoride Toothpaste OPTIC WHITE ADVANCED ICY FRESH is recalled due to improper temperature storage during manufacturing. Approximately 1,680 packages distributed across 11 U.S. states are affected.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2022·2022-09-07

    Triamcinolone Acetonide Cream Recalled for Manufacturing Defects

    Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1643-2022·2022-09-07

    Cell culture medium recalled for improper storage temperature conditions

    Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.

    Product
    AIM-V Medium REF AV.200/500
    Category
    Medical Device
    Distribution
    7 states
  • ModerateCPSC·22213·2022-09-01

    Sun Joe Cordless Lawn Mowers Recalled for Blade Detachment Risk

    Snow Joe is recalling approximately 26,300 Sun Joe cordless lawn mowers (models 24V-X2-17LM and 24V-X2-17LM-CT) because the mower blade can detach unexpectedly, posing a laceration hazard.

    Product
    Sun Joe Cordless Lawn Mowers models 24V-X2-17LM and 24V-X2-17LM-CT
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1635-2022·2022-08-31

    Dynarex DynaLube Lubricating Jelly Recalled Due to Temperature Excursions

    Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.

    Product
    DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
    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-1453-2022·2022-08-31

    Robitussin and Delsym Cough Medications Recalled for Storage Temperature Violations

    Family Dollar Stores is recalling Robitussin Cough N Chest Congestion (4 FL OZ, SKU 919471) and Delsym Orange (3 FL OZ, SKU 901880) because these medications were stored outside proper temperature conditions.

    Product
    ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1610-2022·2022-08-31

    Medline Catheter Plugs Recalled for Potential Temperature Exposure Impact

    Mckesson Medical-Surgical is recalling Medline catheter plugs (Model DYND12200) due to temperature excursions that may have impacted effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1370-2022·2022-08-31

    Deodorant and Antiperspirant Products Recalled for Temperature Storage Deviations

    Family Dollar Stores is recalling multiple deodorant and antiperspirant products because they were stored outside appropriate temperature conditions. No illnesses or injuries have been reported.

    Product
    SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SKU 2004622 LADY SPEED STICK AP WILD FREESSIA 1.4OZ SKU 2005184 SUAVE AP DEOD POWDER 2.6 OZ 2PK SKU 2028126 SCRT IN SLD PWDR FRSH 2.1OZ 2PK SKU 2028363 LADY SPD STK AP INV PWDR 1.4OZ SKU 2028365
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Failure

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1461-2022·2022-08-31

    QP Cough Cold Tablets Recalled for Improper Storage Conditions

    QP Cough Cold Tablet 16 CT units distributed to specific Family Dollar Stores nationwide are being recalled due to storage temperature deviations. No illnesses or injuries have been reported.

    Product
    QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1411-2022·2022-08-31

    Swan Calamine Lotion Nationwide Recall for Temperature Storage Deviations

    Family Dollar Stores is recalling Swan Calamine Lotion 6 FL OZ due to CGMP deviations involving improper storage temperature. No illnesses or injuries have been reported.

    Product
    SWAN CALAMINE LOTION 6 FL OZ 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 (Devices)·Z-1633-2022·2022-08-31

    Dynarex Cotton Swabs Recalled Due to Temperature Exposure

    Mckesson Medical-Surgical is recalling Dynarex cotton swabs (197 boxes) received June 1–September 30, 2021, due to temperature excursions during storage that may have reduced product effectiveness.

    Product
    DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202
    Category
    Medical Device
    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-1619-2022·2022-08-31

    McKesson Medefil Normal Saline IV Flush Syringes Recalled for Temperature Exposure

    McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.

    Product
    a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2022·2022-08-31

    Nicorette Gum Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling NICORETTE GUM WHITE ICE MINT 4 MG distributed from April 30 through June 10, 2022. The product was held outside appropriate storage temperature conditions.

    Product
    NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1371-2022·2022-08-31

    Liquid Hand Soaps and Cleaning Products Recalled for Storage Temperature Deviations

    Family Dollar is recalling multiple liquid hand soaps and cleaning products that were stored at improper temperatures during distribution.

    Product
    SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTS
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1376-2022·2022-08-31

    Aleve Analgesic Products Recalled Due to Improper Storage Temperature Conditions

    Family Dollar is recalling three Aleve products due to storage temperature deviations. Products were held outside appropriate conditions from April 30 through June 10, 2022.

    Product
    ALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900442 ALEVE CAPLET 50 CT SKU 916980 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1460-2022·2022-08-31

    Mucinex SE Max Strength recalled for improper storage conditions

    Family Dollar Stores is recalling Mucinex SE Max Strength 7CT distributed from April through June 2022 due to CGMP deviations involving improper storage temperature.

    Product
    MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide