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.

101–125 of 188

  • ModerateFDA (Drugs)·D-0609-2018·2018-04-04

    Bracco Recalls E-Z-Paste Barium Sulfate Due to Preservative Failure

    Bracco Diagnostics is recalling E-Z-Paste Barium Sulfate Esophageal Cream because one lot failed stability testing for the preservative methylparaben.

    Product
    E-Z-PASTE — E-Z-PASTE (BARIUM SULFATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2018·2018-03-21

    Vygon IV Start Convenience Kits Recalled for Iodine Stability Issues

    Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.

    Product
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0598-2018·2018-03-21

    Dr. Reddy's Recalls Clocortolone Pivalate Cream Due to Stability Issues

    Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.

    Product
    Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0914-2018·2018-03-14

    Ranitidine Tablets Recalled for Failed Stability Specifications

    Mckesson Packaging Services is recalling Ranitidine Tablets 150 mg due to failed stability specifications. The recall affects 17,192 cartons distributed nationwide.

    Product
    RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0545-2018·2018-03-07

    Allergan Recalls Iron Dextran Injection Due to Stability Failures

    Allergan is recalling INFeD (Iron Dextran Injection USP) because stability testing showed the product did not meet specifications for iron content.

    Product
    INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0807-2018·2018-03-07

    Ortho Recalls VITROS Performance Verifier II Due to Stability Issues

    Ortho Clinical Diagnostics is recalling VITROS Performance Verifier II Lot K4852 because it fails long-term stability requirements for the AST analyte when refrigerated.

    Product
    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0417-2018·2018-02-21

    Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure

    Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0231-2018·2018-01-31

    Odan Laboratories Recalls Day Cream SPF15 Due to Stability Failure

    Odan Laboratories is recalling 21 jars of Day Cream SPF15 because the product failed stability specifications at 12 months.

    Product
    Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0232-2018·2018-01-31

    Odan Laboratories Recalls Dry to Normal Skin Starter Kit for Stability Failure

    Odan Laboratories is recalling 179 kits of Dry to Normal Skin Starter Kit because the product failed stability specifications at 12 months.

    Product
    Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2018·2018-01-17

    Allergan Recalls One Lot of Viokace Tablets Due to Stability Testing Failures

    Allergan is recalling one lot of Viokace tablets because stability testing results did not meet specifications for enzyme profile.

    Product
    Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0135-2018·2018-01-03

    Bayer Chewable Low Dose Aspirin Recalled for Failed Stability Specifications

    Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.

    Product
    Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0074-2018·2017-11-22

    Amerisource Recalls Enalapril Maleate Tablets Due to Stability Failures

    Amerisource Health Services is recalling Enalapril Maleate Tablets, 5 mg, because the product failed stability specifications.

    Product
    Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0073-2018·2017-11-01

    Vi-Jon Recalls Equate and Studio 35 Face Moisturizers for Stability Failures

    Vi-Jon, Inc. is recalling Equate and Studio 35 Clarifying Face Daily Moisturizers because the products failed stability specifications. The recall covers 67,532 bottles distributed nationwide.

    Product
    Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmo
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2018·2017-10-25

    Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity

    Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.

    Product
    BISOPROLOL FUMARATE — BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2017·2017-06-07

    Siemens SHBG Immulite 2000 Reagent Recall Due to Stability Issues

    Siemens is recalling certain lots of SHBG Immulite 2000 reagents because they may not meet stability claims, potentially causing test bias.

    Product
    SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0858-2017·2017-05-31

    Strides Pharma Recalls Benzonatate Capsules for Stability Failure

    Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0703-2017·2017-05-17

    Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.

    Product
    PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0676-2017·2017-04-26

    Taro Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failures

    Taro Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream because it failed content uniformity specifications during 18-month stability testing.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2017·2017-04-05

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole tablets because they failed dissolution and stability specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide