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.

6651–6675 of 21595

  • ModerateFDA (Devices)·Z-2706-2020·2020-08-05

    Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery

    Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.

    Product
    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope u
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1438-2020·2020-08-05

    MasterPharm Recalls Tadalafil 26 mg Capsules Due to Processing Controls

    MasterPharm LLC is recalling Tadalafil 26 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1425-2020·2020-08-05

    MasterPharm Recalls Minoxidil/Biotin Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Minoxidil/Biotin 1.25mg/5mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2020·2020-08-05

    MasterPharm Recalls Tadalafil 7 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 7 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1421-2020·2020-08-05

    MasterPharm Recalls Estriol 8 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Estriol 8 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1037-2020·2020-08-05

    Built Brands Recalls Cookie Dough Protein Bars for Potential Mold

    Built Brands LLC is recalling specific lots of Cookie Dough Chocolate covered protein bars because they may be moldy before the expiration date.

    Product
    Cookie Dough Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1418-2020·2020-08-05

    MasterPharm Recalls Calcium Citrate Powder Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 24 grams of Calcium citrate tetrahydrate USP powder due to a lack of processing controls that ensures conformity to specifications.

    Product
    Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1424-2020·2020-08-05

    MasterPharm Recalls Formula 82M Due to Lack of Processing Controls

    MasterPharm LLC is recalling 543 units of Formula 82M topical solution nationwide because the product lacks assurance of conformity to specifications.

    Product
    Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1034-2020·2020-08-05

    Built Brands Recalls Banana Nut Bread Chocolate Covered Protein Bars

    Built Brands LLC is recalling 333,420 Banana Nut Bread Chocolate covered protein bars because they may be moldy prior to the end of the stated shelf life.

    Product
    Banana Nut Bread Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2020·2020-08-05

    Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction

    Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.

    Product
    regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2020·2020-08-05

    Steris InnoWave Sonic Irrigator Recalled for Unclear Installation Test Criteria

    Steris Corporation is recalling 1,283 InnoWave Sonic Irrigators because an FDA inspection found that the foil test performed during installation lacks clear acceptance criteria.

    Product
    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1419-2020·2020-08-05

    MasterPharm Recalls D-Biotin 300 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling D-Biotin 300 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1441-2020·2020-08-05

    MasterPharm Recalls Testosterone/Anastrozole Pellets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Testosterone/Anastrozole Pellets 100/6 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1443-2020·2020-08-05

    MasterPharm Recalls Yohimbine HCL Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Yohimbine HCL 5.4mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1437-2020·2020-08-05

    MasterPharm Recalls Tadalafil 18 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 18 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1042-2020·2020-08-05

    Built Brands Recalls Toffee Almond Chocolate Protein Bars Due to Mold Risk

    Built Brands LLC is recalling Toffee Almond Chocolate covered protein bars because they may be moldy before the expiration date.

    Product
    Toffee Almond Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1433-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 600 capsules of Progesterone Modified Release 100 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1041-2020·2020-08-05

    Built Brands Recalls Black Cherry Chocolate Creme Protein Bars for Mold

    Built Brands LLC is recalling 121,190 Black Cherry Chocolate Creme protein bars because they may be moldy before the expiration date.

    Product
    Black Cherry Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1038-2020·2020-08-05

    Built Brands Recalls Double Chocolate Mousse Protein Bars Due to Mold

    Built Brands LLC is recalling Double Chocolate Mousse protein bars because they may be moldy before the expiration date. The recall covers 48,480 bars distributed in the U.S. and Canada.

    Product
    Double Chocolate Mousse Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2020·2020-08-05

    Synthes Recalls MatrixMIDFACE Screws Due to Incorrect Size Marking

    Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Screws because the body clip was etched with the wrong size number.

    Product
    MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1040-2020·2020-08-05

    Built Brands Recalls S'Mores Chocolate Covered Protein Bars for Mold Risk

    Built Brands LLC is recalling S'Mores Chocolate covered protein bars because they may be moldy before the expiration date.

    Product
    S'Mores Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1432-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Progesterone 50 mg Modified Release Capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1409-2020·2020-08-05

    Allergan Recalls Subpotent Skin Medica Acne Treatment Lotion

    Allergan is recalling specific lots of Skin Medica Acne Treatment Lotion because the products failed potency tests at 12 and 24 months.

    Product
    Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2020·2020-08-05

    TTDEYE Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Diamonds Starlight colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide