The Recall Desk

Hazard

Failed Specifications recalls

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

What the numbers show

Total
15
Critical
0
Severe
1
Most recent
2025-06-18

Of the 15 failed specifications recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all failed specifications 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.

1–15 of 15

  • ModerateFDA (Drugs)·D-0497-2025·2025-06-18

    Icosapent Ethyl Capsules Recalled for Failed Tablet Specifications

    Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to burnt or melted capsules caused by oxidation from leakage of capsule contents. The recall affects 11,616 bottles distributed in Illinois, Pennsylvania, and Mississippi.

    Product
    ICOSAPENT ETHYL — ICOSAPENT ETHYL (ICOSAPENT ETHYL)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1086-2023·2023-08-23

    Tobramycin Ophthalmic Solution recalled for failed quality specifications

    Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution nationwide because the product failed to meet impurities and degradation specifications.

    Product
    TOBRAMYCIN OPHTHALMIC SOLUTION — TOBRAMYCIN OPHTHALMIC SOLUTION (TOBRAMYCIN OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0576-2022·2022-03-02

    Azacitidine 100mg Intravenous/Subcutaneous Drug Recall

    Dr. Reddy's Laboratories is recalling Azacitidine 100mg vials distributed nationwide due to failed stability specifications. The recall affects six lots with expiration dates ranging from August 2023 to April 2024.

    Product
    AZACITIDINE — AZACITIDINE (AZACITIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2022·2022-03-02

    Methylphenidate Hydrochloride Chewable Tablets Recalled for Failed Specifications

    Rising Pharmaceuticals is voluntarily recalling Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, due to a tablet size defect. One tablet in a sealed bottle was found to be twice the size of other tablets in the same bottle.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2022·2022-02-02

    Pioglitazone Tablets Recalled for Superpotent and Failed Specifications

    Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.

    Product
    PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0330-2022·2022-01-12

    Amazon Allergy Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Specifications

    Amazon-branded Allergy Fexofenadine Hydrochloride Tablets 180 mg are being recalled because testing found an out-of-specification impurity during stability testing.

    Product
    amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2022·2021-11-24

    Clonidine Transdermal System patches recalled for impurities and degradation

    Teva Pharmaceuticals USA is recalling 64,978 Clonidine Transdermal System patches (0.1 mg/day) due to failed specifications for impurities and degradation. The recall affects nationwide and Puerto Rico distribution.

    Product
    CLONIDINE TRANSDERMAL SYSTEM — CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0081-2022·2021-11-10

    Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure

    Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets nationwide because the product was manufactured using an excipient that failed to meet conductivity specifications.

    Product
    EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0689-2021·2021-07-28

    Erythromycin Topical Solution 2% Recalled for Failed Impurities Specifications

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.

    Product
    Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0639-2021·2021-06-30

    Phytonadione 5 mg Tablets Recalled for Failed Impurity Specifications

    Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.

    Product
    Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1449-2016·2016-08-03

    Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications

    Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.

    Product
    Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0952-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0953-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide