The Recall Desk

Hazard

Out Of Specification recalls

168 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all out of specification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–100 of 168

  • ModerateFDA (Drugs)·D-0537-2025·2025-07-30

    Clomipramine capsules failed a degradation product specification at expiry testing

    Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0524-2025·2025-07-23

    Levothyroxine sodium 175 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2025·2025-07-23

    Levothyroxine sodium 112 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0523-2025·2025-07-23

    Levothyroxine sodium 150 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2025·2025-07-23

    Levothyroxine sodium 50 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 50 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 54,227 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0521-2025·2025-07-23

    Levothyroxine sodium 100 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 100 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 9,739 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2025·2025-07-23

    Levothyroxine sodium 25 microgram bottles of 1000 assayed below specification

    Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0518-2025·2025-07-23

    Levothyroxine sodium 25 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2025·2025-07-23

    Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability

    Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0390-2025·2025-05-07

    Tirofiban Hydrochloride Injection recalled for out-of-specification test results

    Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during a three-month stability study under long-term storage conditions.

    Product
    TIROFIBAN — TIROFIBAN (TIROFIBAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2025·2025-03-26

    Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency

    Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2024·2024-07-10

    Dodex Injectable Cyanocobalamin Recalled Due to Subpotent Drug Defect

    Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.

    Product
    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2024·2024-06-05

    Pain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2024·2024-06-05

    Bull Frog SPF 50 Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion nationwide due to the active ingredient being out of specification. Consumers with affected lots should not use the product and contact the manufacturer.

    Product
    Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2024·2024-06-05

    Pain Wizard topical pain relief recalled for manufacturing specification violation

    ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0523-2024·2024-06-05

    Aloe Gator SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredients

    ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2024·2024-06-05

    Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance

    Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2024·2024-05-29

    Medical syringes recalled due to manufacturing specification deviation

    Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide