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.

76–100 of 188

  • ModerateFDA (Drugs)·D-1062-2020·2020-04-01

    Jubilant Draximage Recalls DRAXIMAGE DTPA Kits Due to Stability Failures

    Jubilant Draximage is recalling DRAXIMAGE DTPA kits because they failed stability specifications. The affected product was distributed throughout the United States.

    Product
    DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1517-2019·2019-07-31

    Tris Pharma Recalls Hydrocodone and Chlorpheniramine Suspension Due to Potency Issues

    Tris Pharma is recalling 2,550 bottles of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension due to high out-of-specification results for active ingredients and preservatives.

    Product
    HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX — HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1518-2019·2019-07-31

    Lupin Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failure

    Lupin Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream due to a failed uniformity of containers test. The recall covers 33,939 tubes distributed nationwide.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1396-2019·2019-06-19

    Bausch & Lomb Recalls Lotemax Ophthalmic Gel for Viscosity Issues

    Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.

    Product
    LOTEMAX — LOTEMAX (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1338-2019·2019-05-22

    Integra Flowable Wound Matrix Recalled for Stability Failure

    Integra Limited is recalling 274 units of Integra Flowable Wound Matrix (Lot 2991332) because the product failed stability testing for visual appearance and force displacement.

    Product
    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehisce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2019·2019-02-27

    Akorn Recalls Moisturizing Lubricant Eye Drops Due to Stability Failure

    Akorn Inc is recalling specific lots of Moisturizing Lubricant Eye Drops because they failed stability specifications for Sodium Perborate.

    Product
    Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2019·2019-02-27

    Akorn Recalls Clobetasol Propionate Cream Due to Preservative Stability Failure

    Akorn Inc. is recalling specific lots of Clobetasol Propionate Emollient Cream 0.05% because stability testing revealed out-of-specification preservative levels.

    Product
    Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0483-2019·2019-02-20

    Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures

    Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.

    Product
    COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2019·2018-12-05

    Allergan Recalls INFed Iron Dextran Injection for Stability Failure

    Allergan is recalling INFed (Iron Dextran Injection) vials because they failed stability specifications for iron content. The product was distributed throughout the United States.

    Product
    INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0279-2019·2018-11-21

    Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures

    Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.

    Product
    Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0082-2019·2018-10-24

    Teva Recalls Clonazepam Tablets Due to Failed Stability Specifications

    Teva Pharmaceuticals is recalling 1,373 cartons of Clonazepam Orally Disintegrating Tablets because routine stability testing revealed out-of-specification water content.

    Product
    Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0065-2019·2018-10-24

    Product Quest Recalls Dr. Brandt BB Cream for Stability Failures

    Product Quest Manufacturing LLC is recalling 9,480 tubes of Dr. Brandt BB Cream with SPF 30 due to failed stability specifications, including product separation.

    Product
    dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0007-2019·2018-10-10

    Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures

    Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.

    Product
    Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1205-2018·2018-09-26

    Jubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure

    Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets due to failed stability testing. The product was distributed throughout the United States.

    Product
    MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1184-2018·2018-09-19

    Pfizer Recalls Argatroban Injection Vials Due to Stability Testing Failures

    Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1032-2018·2018-08-08

    Fluconazole Injection Recalled for Elevated Water Vapor Levels

    Renaissance Lakewood, LLC is recalling Fluconazole Injection bags due to elevated water vapor levels. The recall covers 3,664 bags distributed nationwide and in Puerto Rico.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1031-2018·2018-08-08

    Renaissance Lakewood Recalls Fluconazole Injection Bags Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 3,000 bags of Fluconazole Injection due to elevated sodium chloride and water vapor levels.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0991-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg due to out-of-specification results for a degradation product during commercial stability.

    Product
    Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0908-2018·2018-07-11

    Eb5 Age Spot Treatment Cream Recalled for Stability Failures

    Eb5 Corporation is recalling 4,632 tubes of Age Spot Treatment Cream because the product failed stability specifications for viscosity, pH, and specific gravity.

    Product
    eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0857-2018·2018-05-30

    Teva Recalls Lidocaine Patches Due to Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0815-2018·2018-05-23

    Pharmalucence Recalls Technetium TC 99M Mebrofenin Kits for Stability Failures

    Pharmalucence, Inc. is recalling Technetium TC 99M Mebrofenin kits nationwide because they failed stability specifications.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN — KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2018·2018-04-11

    Phadia Recalls ImmunoCAP Allergen c5 Ampicilloyl Test Kits

    Phadia US Inc is recalling ImmunoCAP Allergen c5, Ampicilloyl test kits because stability specifications were not met.

    Product
    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2018·2018-04-11

    Phadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures

    Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.

    Product
    ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 500
    Category
    Medical Device
    Distribution
    Distributed nationwide