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.

4301–4325 of 21589

  • ModerateFDA (Drugs)·D-1396-2022·2022-08-31

    Preferred Urinary Pain Relief Product Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Preferred Urinary Pain Relief Max Strength due to CGMP violations involving improper storage temperature. Product was distributed nationwide April 30 through June 10, 2022.

    Product
    PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1435-2022·2022-08-31

    Four Topical Analgesic Products Recalled for Improper Storage Conditions

    Four topical analgesic products distributed to Family Dollar stores were recalled due to CGMP violations involving improper storage temperature conditions. No illnesses or injuries have been reported.

    Product
    ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT MUSCLE RUB 1.25 OZ SKU 920205 ICY HOT NO MESS 1.5 OZ SKU 998751 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1452-2022·2022-08-31

    Three allergy medications recalled due to improper storage conditions

    Family Dollar Stores is recalling three allergy medication products that were stored outside appropriate temperature ranges, violating Good Manufacturing Practice standards.

    Product
    READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2022·2022-08-31

    McKesson Pregnancy Test Kits Recalled for Temperature Exposure During Storage

    McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.

    Product
    a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1459-2022·2022-08-31

    QP Cold Multi-Symptom medication recalled for improper storage conditions

    Family Dollar Stores is recalling QP Cold Multi-Symptom Day/Night medication distributed April 30–June 10, 2022, to select stores because the product was held at incorrect temperatures. Consumers should return the product to the store for a refund.

    Product
    QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2022·2022-08-31

    IV Securement Kit Recall Due to Storage Temperature Damage

    McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.

    Product
    MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3
    Category
    Medical Device
    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 (Devices)·Z-1603-2022·2022-08-31

    DisCide Ultra Surface Disinfectant Recalled Due to Temperature Exposure

    McKesson Medical-Surgical's DisCide Ultra Surface Disinfectant Cleaner is being recalled because temperature excursions may have reduced product effectiveness. The recall affects all lots distributed nationwide between June and September 2021.

    Product
    Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1415-2022·2022-08-31

    Alka Seltzer Extra Strength 24 CT Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Alka Seltzer Extra Strength 24 CT due to products stored outside proper temperature conditions, which may affect product quality.

    Product
    ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1547-2022·2022-08-24

    KY Jelly Lubricant Recalled for Improper Storage Conditions

    KY Jelly Lubricant 2 FL OZ (SKU 901443) distributed at Family Dollar stores was not stored in temperature-controlled areas. Consumers should discontinue use of product purchased between May–June 2022.

    Product
    KY JELLY LUBRICANT 2 FL OZ, SKU 901443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2022·2022-08-24

    At-home marijuana test strips recalled for improper storage

    Family Dollar is recalling at-home marijuana test strips (SKU 900752) that were stored outside temperature-controlled areas. Improper storage may affect test accuracy.

    Product
    AT HOME MARIJUANA TEST STRIP, SKU 900752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1357-2022·2022-08-24

    Stage 2-Ophardt Foaming Hand Sanitizer Recalled Due to Microbial Control Deviation

    Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2022·2022-08-24

    Polident Denture Cleansers Recalled Due to Improper Storage

    Polident denture cleansers sold at Family Dollar stores nationwide are being recalled due to improper storage conditions. No illnesses or injuries have been reported.

    Product
    POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2022·2022-08-24

    CURAD Waterproof Bandages Recalled for Improper Storage

    Family Dollar is recalling CURAD waterproof bandages due to improper storage outside temperature-controlled conditions. The recall affects approximately 419 units sold nationwide between May 1 and June 10, 2022.

    Product
    CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1534-2022·2022-08-24

    Denture Cleanser Tablets Recalled for Improper Storage Conditions

    Family Dollar is recalling GS Denture Cleanser tablets (green and overnight formulas) due to improper storage in non-temperature-controlled areas. Products sold May 1 - June 10, 2022 may be affected.

    Product
    GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2022·2022-08-24

    Contact Lens Solution Recalled for Improper Temperature Storage

    OPTI FREE REPLENISH contact lens solution sold at Family Dollar stores (May 1–June 10, 2022) was not stored in temperature-controlled areas and is being recalled.

    Product
    OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2022·2022-08-24

    Akorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints

    Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets because the imprint identification marking is missing from the tablets. The recall affects 30,325 bottles distributed to wholesalers.

    Product
    Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1335-2022·2022-08-24

    Drug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits

    Heron Therapeutics is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) distributed nationwide because one lot contains an incorrect syringe in the delivery system. No illnesses or injuries have been reported.

    Product
    ZYNRELEF — ZYNRELEF (BUPIVACAINE AND MELOXICAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1349-2022·2022-08-24

    Azacitidine for Injection Recalled Nationwide for Subpotent Dosage

    Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.

    Product
    Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2022·2022-08-24

    VeriQuick Pregnancy Tests Recalled Due to Improper Storage

    Family Dollar is recalling VeriQuick pregnancy tests that were not stored in temperature-controlled areas between April-June 2022. Improper storage conditions may affect test accuracy.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2022·2022-08-24

    Temporary Dental Filling Product Recalled for Improper Storage

    Family Dollar is recalling DENTEMP temporary dental filling products (SKU 902139) that were stored outside temperature-controlled conditions. The product was sold at Family Dollar stores nationwide between May and June 2022.

    Product
    DENTEMP ONE STEP .077OZ, SKU 902139
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1352-2022·2022-08-24

    Acetaminophen 325 mg tablets recalled for missing imprint

    Akorn Pharma is recalling 301,382 bottles of Acetaminophen 325 mg tablets because the tablets lack the required "AP 325" imprint marking.

    Product
    Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1558-2022·2022-08-24

    Sensis Signal Input Box recall for patient electrical leakage hazard with improper mounting

    Siemens recalls 399 units of AXIOM Sensis systems due to risk of patient electrical shock if the Signal Input Box mounting deviates from its default position.

    Product
    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2022·2022-08-24

    Travel Kit Toothbrush and Toothpaste Recalled Due to Improper Storage

    Family Dollar is recalling approximately 1,555 travel kit toothbrush and toothpaste pouches that were stored in non-temperature-controlled areas. Products sold between May 1 and June 10, 2022 are affected.

    Product
    TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
    Category
    Consumer Product
    Distribution
    Distributed nationwide