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.

26–50 of 188

  • ModerateFDA (Drugs)·D-0472-2025·2025-06-25

    Gentamicin Injection Pediatric Vials Recalled for Failed Stability Tests

    Eugia US LLC is recalling Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL due to failed color absorbance test results during 12-month stability analysis. The recall affects 48,000 vials distributed nationwide.

    Product
    GENTAMICIN — GENTAMICIN (GENTAMICIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2025·2025-05-28

    Esomeprazole Magnesium oral suspension recalled for failed impurity specifications

    Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    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-0298-2025·2025-04-02

    Babyganics Mineral Sunscreen Recalled for Failed Stability Specifications

    Babyganics Sheer Blend SPF 50 Mineral Sunscreen is being recalled nationwide because ingredients separated during stability testing, prompting an FDA Class II recall.

    Product
    babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0218-2025·2025-02-12

    Prescription injection recalled for failed stability test results

    Teva Pharmaceuticals is recalling Granix injection due to failed stability test results showing one peptide did not meet specification limits.

    Product
    GRANIX — GRANIX (TBO-FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2025·2025-02-12

    NeiMed NasoGel nasal spray recalled due to stability failure

    Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.

    Product
    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0191-2025·2025-01-15

    FDA Recalls Radiopharmaceutical Kit Due to Failed Stability Specifications

    Jubilant Draximage is recalling 5,209 kits of Technetium Tc 99m Sulfur Colloid Injection that failed stability specifications. The affected lots (C2300070, C2300070E) were distributed nationwide.

    Product
    Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2025·2024-11-06

    OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration

    BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.

    Product
    CHLORPHENIRAMINE MALEATE 4MG — CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0446-2024·2024-04-24

    Thyroid pharmaceutical ingredient recalled for failed stability specifications

    Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.

    Product
    S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0385-2024·2024-03-20

    Antibiotic Injection Recalled for Failed Stability Specification

    Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.

    Product
    TOBRAMYCIN — TOBRAMYCIN (TOBRAMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2024·2024-03-20

    Broncochem Cold & Flu Syrup Kids Recalled Due to Stability Testing Failures

    Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.

    Product
    Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0387-2024·2024-03-20

    FDA Recalls Broncochem Cold & Tea Nationwide for Stability Failures

    Global Corporation is recalling Broncochem Cold & Tea nationwide due to stability testing failures in the active ingredients. No illnesses or injuries have been reported.

    Product
    BRONCOCHEM — BRONCOCHEM (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·24153·2024-03-07

    SINGES 3-in-1 High Chair and Booster Seats Recalled for Fall Hazard

    SINGES 3-in-1 High Chairs and Booster Seats sold on Walmart.com violate federal safety regulations. The product can tip over or collapse, presenting a fall hazard to children. No injuries have been reported.

    Product
    SINGES 3-in-1 Baby High Chairs and Booster Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1145-2023·2023-09-13

    Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications

    Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.

    Product
    FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2225-2023·2023-08-02

    Diagnostic Verification Product May Not Meet Shelf Life Stability Specifications

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.

    Product
    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measuremen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0896-2023·2023-07-19

    Vivus Pancreaze prescription drug recall for failed stability specifications

    Vivus, Inc. is recalling Pancreaze delayed-release capsules nationwide due to failed stability specifications. The affected lot may not maintain product strength through the stated expiration date.

    Product
    PANCREAZE — PANCREAZE (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2023·2023-07-12

    Tizanidine tablets recalled nationwide for failed stability specifications

    Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·23763·2023-06-08

    Narskido Infant Bath Seats Recalled for Drowning Hazard

    TopGlore is recalling about 650 Narskido infant bath seats sold on Amazon because they fail to meet federal safety standards and can tip over, posing a drowning hazard to babies.

    Product
    Narskido Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0265-2023·2023-02-15

    Akorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing

    Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0093-2023·2023-01-04

    Timolol Maleate Ophthalmic Solution recalled for failed stability specifications

    Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·22768·2022-09-01

    Yuboloo Infant Bath Seats Recalled for Drowning Hazard

    Yuboloo is recalling about 1,050 infant bath seats sold on Amazon.com from May to November 2021 because they fail to meet federal safety standards and can tip over in water, posing a drowning hazard to infants.

    Product
    Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2022·2022-08-10

    Medline germicidal bleach wipes recalled due to stability failure

    Medline Micro-Kill Germicidal Bleach Wipes are being recalled nationwide due to stability failure affecting approximately 6.1 million wipes across multiple lot numbers.

    Product
    MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
    Category
    Medical Device
    Distribution
    Distributed nationwide