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.

5301–5325 of 21589

  • ModerateFDA (Drugs)·D-0881-2021·2021-10-06

    ZTE-1020 Homeopathic Formula Recalled for Failed Identification Testing

    Washington Homeopathic Products, Inc. is recalling ZTE-1020 Formula (1000ml bottle, Lot #25740) distributed nationwide because identification testing based on HPTLC analysis produced out-of-specification results.

    Product
    ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcoho
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Body Mist Recalled for cGMP Deviations

    Johnson & Johnson Consumer is recalling Neutrogena Ultra Sheer body mist sunscreen in 5 oz and 8 oz aerosol cans nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNS
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0841-2021·2021-10-06

    Neutrogena Beach Defense SPF 100 sunscreen spray recalled for cGMP deviations

    Johnson & Johnson is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 100, 6.5 oz aerosol cans) nationwide due to cGMP manufacturing deviations. The recall was voluntarily initiated by the company.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2021·2021-10-06

    ZTE-105 Formula Gentle Detoxing Recall Due to Failed Identification Testing

    Washington Homeopathic Products is recalling ZTE-105 Formula Gentle Detoxing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0840-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled Due to cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling 405,264 cans of Neutrogena COOLDRY SPORT Broad Spectrum SPF 100 sunscreen spray nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary recall initiated by the firm.

    Product
    Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0879-2021·2021-10-06

    Z-103 GU DETOXING Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Z-103 GU DETOXING, a 1000ml homeopathic medicine containing 20% alcohol, due to out-of-specification test results on identification testing using HPTLC analysis.

    Product
    Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Ver
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2021·2021-10-06

    Z-107 Formula Soft Tissue Healing Recalled for Out-of-Specification Test Results

    Washington Homeopathic Products, Inc. is recalling Z-107 Formula Soft Tissue Healing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing. The recall affects 562 bottles across multiple potencies and lot 26198.

    Product
    Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2617-2021·2021-10-06

    Xcela PICC catheter mislabeled with incorrect size designation

    Angiodynamics is recalling Xcela PICC catheters where units labeled as 5F are actually 4F. The labeling discrepancy between labeled and actual product size could affect clinical device selection.

    Product
    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0864-2021·2021-10-06

    Washington Homeopathic Cinnamomum Pills Recalled for Failed Identity Testing

    Washington Homeopathic Products is recalling Cinnamomum 6X and 30X homeopathic pills due to failed identification testing results. The products did not meet specifications in HPTLC analysis.

    Product
    Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1020-2021·2021-10-06

    Ferretts IPS Iron Liquid Dietary Supplement Stability Recall

    Monarch PCM, LLC is recalling Ferretts IPS Iron Liquid Dietary Supplement because stability testing shows the product degraded to 81% potency over a 3-month period, falling below specification limits.

    Product
    Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY (5.5 oz, SPF 50) due to cGMP (current Good Manufacturing Practice) deviations. Approximately 1.4 million cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2021·2021-10-06

    Washington Homeopathic Products Homeopathic Medicine Fails Identity Testing

    Washington Homeopathic Products is recalling La Core LCL-2-0191 Blend homeopathic medicine due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0836-2021·2021-10-06

    Neutrogena Ultra Sheer Sunscreen Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is voluntarily recalling Neutrogena Ultra Sheer body mist sunscreen SPF 30 due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.6 million cans distributed nationwide.

    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0008-2022·2021-10-06

    RC Cola 12 oz cans recalled for off flavor and aroma

    Keurig Dr Pepper is recalling RC Cola 12 oz aluminum cans (12-pack) due to consumer complaints of off flavor and aroma. The affected product was distributed to multiple states.

    Product
    Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0884-2021·2021-10-06

    Z-1070 Formula Anxioheal Homeopathic Medicine Recall for Testing

    Washington Homeopathic Products, Inc. is recalling Z-1070 Formula Anxioheal, a 1000ml homeopathic remedy containing 20% alcohol, due to out-of-specification test results from HPTLC identification testing. The product was distributed nationwide.

    Product
    Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50, 6.5 oz aerosol) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and initiated by the firm.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0887-2021·2021-10-06

    ZTE 1013 Formula Antimicrobial Homeopathic Product Recall

    Washington Homeopathic Products is recalling ZTE 1013 Formula Antimicrobial (1000 ml, Lot # 25738) distributed nationwide because testing identified out-of-specification results during identification analysis.

    Product
    ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metal
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2021·2021-10-06

    Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance

    Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.

    Product
    BF-P60 OES Bronchofiberscope, Model No. BF-P60
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2021·2021-10-06

    Drug recall: Daytime/Nighttime Severe Cold & Flu Relief vials subpotent

    New Vision Pharmaceuticals is recalling Daytime and Nighttime Severe Cold & Flu Relief single-use vials because the drug is subpotent—meaning it contains less active ingredient than intended. The recall was initiated voluntarily on September 2, 2021.

    Product
    Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057
    Category
    Drug
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0878-2021·2021-10-06

    Viola od Homeopathic Medicine Recall for Failed Identity Testing

    Washington Homeopathic Products is recalling Viola od 6X and 30X homeopathic pills (Lot #29057) distributed nationwide due to out-of-specification results in identity testing using HPTLC analysis.

    Product
    Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dram, UPC 7 40640 50139 9; 30X Packaged in b) 4 dr, UPC 7 40640 50141 2; c) 2 oz, UPC 7 40640 50149 8; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2021·2021-10-06

    Strophanthus Hisp 30X Homeopathic Medicine Fails Identification Test

    Washington Homeopathic Products is recalling 91 bottles of Strophanthus hisp 30X for Hives due to failed identification testing. The product did not meet specifications in HPTLC analysis and was distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1021-2021·2021-10-06

    HEB Jumbo Stuffed Shells Recalled for Possible Metal Contamination

    HEB Jumbo Stuffed Shells filled with ricotta and romano cheese may contain metal fragments. The product was distributed in Texas under item number 796702 with a sell-by date of 07/27/2022.

    Product
    HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g
    Category
    Food
    Distribution
    1 state