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.

51–75 of 188

  • HighFDA (Drugs)·D-0875-2022·2022-05-25

    Lupin Pharmaceuticals Recalls GaviLyte-C Laxative Powder Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2022·2022-03-23

    Hologic Panther Fusion Extraction Reagent-X May Produce False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.

    Product
    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0700-2022·2022-03-09

    Helix Elite Molecular Standard Fails FDA Shelf-Life Stability Testing

    Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2022·2022-03-09

    Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing

    Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.

    Product
    Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use
    Category
    Medical Device
    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-0577-2022·2022-03-02

    Bortezomib 3.5 mg Vials Recalled Due to Failed Stability Specifications

    Dr. Reddy's Laboratories is recalling Bortezomib 3.5 mg single-dose vials nationwide due to failed stability specifications. Approximately 2,980 vials of lot H210233 (expiration 3/1/2023) are affected.

    Product
    Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0575-2022·2022-03-02

    Dr. Reddy's Azacitidine Injectable Drug Recalled for Failed Stability

    Dr. Reddy's Laboratories is recalling Azacitidine 100mg injectable vials nationwide due to failed stability specifications. Multiple lot numbers distributed across the United States are affected.

    Product
    AZACITIDINE — AZACITIDINE (AZACITIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2022·2022-01-12

    CAREONE Allergy Relief 180 mg Tablets Recalled for Failed Impurities Specifications

    Perrigo Company PLC is recalling CAREONE Allergy Relief (Fexofenadine HCL) 180 mg tablets nationwide because stability testing found impurity A out of specification.

    Product
    CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2022·2022-01-12

    Gatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.

    Product
    Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0077-2022·2021-11-03

    Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability

    Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.

    Product
    Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0091-2022·2021-11-03

    Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.

    Product
    Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0071-2022·2021-11-03

    Vica-Cet Back Pain Relief tablets recalled for stability specification failure

    Ultra Seal Corporation is recalling Vica-Cet Back Pain Relief tablets nationwide because certain lots failed stability testing and contain out-of-specification levels of Salicylic Acid, an aspirin-related compound.

    Product
    Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0072-2022·2021-11-03

    ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).

    Product
    ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0726-2021·2021-08-25

    Gavilyte-C Oral Solution Recalled for Failed Stability Specification

    Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2021·2021-08-25

    Combipatch Transdermal Patch Recall Due to Stability Failure

    Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0655-2021·2021-07-21

    LEUKINE (Sargramostim) Injection Recalled for Failed Stability Specification

    Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.

    Product
    LEUKINE — LEUKINE (SARGRAMOSTIM)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2039-2021·2021-07-14

    FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

    BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

    Product
    FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2012-2021·2021-07-14

    ACE Control Set stability claim failure requires updated handling instructions

    Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.

    Product
    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2021·2020-12-16

    Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test results.

    Product
    3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0115-2021·2020-12-09

    InvaTech Recalls Levocetirizine Dihydrochloride Tablets Due to Stability Failure

    InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.

    Product
    Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0003-2021·2020-10-07

    Teva Recalls Buprenorphine Transdermal Patches for Stability Failures

    Teva Pharmaceuticals USA is recalling Buprenorphine Transdermal Systems because they failed stability specifications for release rate.

    Product
    BUPRENORPHINE — BUPRENORPHINE (BUPRENORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1513-2020·2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1512-2020·2020-08-26

    Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

    Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

    Product
    Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1257-2020·2020-05-06

    B. Braun Recalls Ceftazidime and Dextrose Injection Due to Stability Failures

    B. Braun Medical Inc. is recalling one lot of Ceftazidime for Injection USP and Dextrose for Injection USP because the product failed stability specifications for high molecular weight polymers.

    Product
    Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
    Category
    Drug
    Distribution
    Distributed nationwide