The Recall Desk

Hazard

Stability Issue recalls

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

What the numbers show

Total
66
Critical
0
Severe
16
Most recent
2026-08-12

Of the 66 stability issue recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (24%) are Severe.

Which agencies issued them

About this hazard tag

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

1–25 of 66

  • ModerateFDA (Devices)·Z-2896-2026·2026-08-12

    5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues

    Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Control, Model Number 5D-44905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2895-2026·2026-08-12

    Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues

    Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.

    Product
    5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2024·2024-02-28

    Medline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling

    Medline is recalling 1.3 million units of bleach germicidal wipes due to stability concerns. Products labeled for 24-month shelf life are only safe and effective for 12 months.

    Product
    These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC35141
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0097-2024·2023-11-15

    Zydus oxybutynin extended-release tablets recalled nationwide for failed stability testing

    Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0794-2023·2023-06-07

    Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability

    Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.

    Product
    Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0719-2022·2022-03-30

    FDA Recalls NAD+ Injection Due to Sub-Potency and Stability Concerns

    Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide injection vials nationwide due to sub-potency or exceeded reconstitution time.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0684-2022·2022-03-30

    Fluocinonide Gel Recalled for Manufacturing Process Deviations

    Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.

    Product
    Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0151-2022·2021-10-27

    HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall

    Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.

    Product
    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues

    Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.

    Product
    Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0918-2018·2018-07-18

    SCA Pharmaceuticals Recalls Subpotent Buffered Lidocaine Injection

    SCA Pharmaceuticals is recalling 3,984 syringes of Buffered Lidocaine 1% Injection because stability data does not support the current expiration dating.

    Product
    Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2280-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0614-2018·2018-04-04

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 144 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0117-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL syringes because stability data does not support the product's expiry date.

    Product
    NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0118-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin injection syringes because stability data does not support the product's expiry date.

    Product
    NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2165-2017·2017-06-07

    Pointe Scientific Lactate Dehydrogenase Reagent Set Recalled for Stability Issues

    Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase Reagent Sets because the product's stability claim is not being met.

    Product
    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Stability Issues

    Smith & Nephew is recalling 2017 units of Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2017·2017-03-29

    BioMerieux Recalls ETEST Fosfomycin Strips Due to Unsupported Shelf-Life Claims

    BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.

    Product
    ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2017·2017-03-29

    BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2017·2017-03-29

    BioMerieux Recalls ETEST Doripenem Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.

    Product
    ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2017·2017-03-29

    BioMerieux Recalls ETEST Cephalothin CE 256 Foam Packaging Due to Stability Issues

    BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.

    Product
    ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.

    Product
    ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcu
    Category
    Medical Device
    Distribution
    Distributed nationwide