The Recall Desk

Hazard

Stability Failure recalls

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

What the numbers show

Total
188
Critical
0
Severe
9
Most recent
2026-09-02

Of the 188 stability failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (5%) 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 stability failure 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.

126–150 of 188

  • ModerateFDA (Drugs)·D-0446-2017·2017-02-01

    Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.

    Product
    buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2017·2017-02-01

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets because they failed dissolution specifications and a 18-month stability time point.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0326-2017·2017-01-11

    Qualitest Recalls Temazepam Capsules Due to Failed Stability Specifications

    Vintage Pharmaceuticals is recalling 1,200 bottles of Temazepam 7.5 mg capsules because they failed stability specifications. The affected lot is distributed nationwide.

    Product
    TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0779-2017·2016-12-28

    PerkinElmer Recalls DELFIA hFSH Kits Due to Stability Testing Failures

    PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.

    Product
    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0763-2017·2016-12-21

    Oculus Recalls Ceramax Skin Barrier Cream Professional Samples

    Oculus Innovative Sciences is recalling professional samples of Ceramax Skin Barrier Cream because they are not meeting stability standards.

    Product
    Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with var
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0169-2017·2016-12-14

    Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures

    Hospira Inc. is recalling specific lots of 5% Lidocaine HCL and 7.5% Dextrose Injection because they failed stability specifications for color and pH.

    Product
    5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0152-2017·2016-11-30

    Akorn Recalls Desoximetasone Ointment for Stability Failures

    Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.

    Product
    Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0148-2017·2016-11-30

    Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content

    Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.

    Product
    KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0117-2017·2016-11-09

    Taro Recalls Desoximetasone Cream Due to Stability Test Failures

    Taro Pharmaceuticals is recalling specific lots of Desoximetasone Cream 0.05% because they failed stability specifications for homogeneity.

    Product
    DESOXIMETASONE — DESOXIMETASONE (DESOXIMETASONE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2403-2016·2016-08-24

    OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures

    OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.

    Product
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1618-2016·2016-05-18

    Siemens Syva Emit Methotrexate Assay Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate values.

    Product
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0736-2016·2016-02-10

    Instrumentation Laboratory Recalls HemosIL Plasminogen IVD Kits

    Instrumentation Laboratory is recalling specific lots of HemosIL Plasminogen kits because they do not meet labeled stability claims.

    Product
    HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0162-2016·2015-11-11

    Qualitest Recalls Ranitidine Syrup Due to Preservative Stability Failure

    Vintage Pharmaceuticals is recalling specific lots of Ranitidine Syrup because preservative levels failed stability specifications.

    Product
    RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1147-2015·2015-07-01

    Bracco Recalls E-Z-CAT Dry Barium Sulfate Due to Viscosity Failures

    Bracco Diagnostic Inc. is recalling E-Z-CAT Dry Barium Sulfate for Suspension because the product failed stability specifications for viscosity.

    Product
    E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1138-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Inhalation Powder Due to Stability Failure

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a stability test for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1137-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Due to Failed Stability Testing

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a particle size distribution stability test. The recall covers 19,658 packs distributed in New Jersey.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0983-2015·2015-05-13

    Romark Recalls Alinia Powder for Oral Suspension Due to Stability Failure

    Romark Laboratories is recalling specific lots of Alinia (nitazoxanide) powder for oral suspension because the product failed to meet long-term stability specifications for viscosity.

    Product
    Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1452-2015·2015-04-22

    Integra Flowable Wound Matrix Recalled for Stability Criteria Failures

    Integra LifeSciences is recalling 287 packages of Flowable Wound Matrix because the product failed stability acceptance criteria for visual appearance and force vs. displacement.

    Product
    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0420-2015·2015-04-01

    West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures

    West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0304-2015·2014-12-24

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.

    Product
    Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0819-2015·2014-12-24

    Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure

    Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.

    Product
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0236-2015·2014-11-12

    Sun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Sun Pharma Global Inc. is recalling specific batches of Venlafaxine Hydrochloride Extended-Release Tablets because they failed dissolution specifications and a 12-month stability time point.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2015·2014-11-05

    Micro Labs Recalls Glimepiride Tablets Due to Failed Stability Testing

    Micro Labs USA is recalling specific lots of Glimepiride tablets because they failed stability testing. The affected products were distributed in five states.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-1486-2014·2014-08-06

    Oxycodone Hydrochloride Oral Solution Recalled for Stability Failure

    Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of Oxycodone Hydrochloride Oral Solution due to out-of-specification preservative levels.

    Product
    OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
    Category
    Drug
    Distribution
    Distributed nationwide