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.

151–175 of 188

  • LowFDA (Drugs)·D-1387-2014·2014-06-25

    Novartis Recalls Foradil Aerolizer Due to Stability Testing Failures

    Novartis is recalling Foradil Aerolizer inhalation powder capsules because they failed stability specifications for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-140
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2014·2014-02-19

    Bracco Recalls VoLumen Barium Sulfate Suspension Due to Stability Failure

    Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension because the product failed stability testing for preservative content.

    Product
    VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1080-2014·2014-02-12

    Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-747-2014·2014-01-29

    Teva Recalls Fluconazole Oral Suspension for Low Preservative Content

    Teva Pharmaceuticals is recalling Fluconazole Oral Suspension because the product has preservative levels below the required specification.

    Product
    Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-389-2014·2014-01-01

    Hi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures

    Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension because the product's viscosity and pH levels fell below required specifications.

    Product
    Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-342-2014·2013-12-18

    VistaPharm Recalls Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling specific lots of Phenytoin Oral Suspension because a lidding defect caused the product to fail stability tests for assay and viscosity.

    Product
    Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0383-2014·2013-12-04

    Thermo Fisher Recalls MAS Urinalysis Control Level 1 for Stability Failure

    Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1 because the product failed to meet 30-day open vial stability specifications.

    Product
    MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1062-2013·2013-10-02

    CorePharma Recalls Pyridostigmine Bromide Tablets Due to Stability Failure

    CorePharma is recalling 960 bottles of Pyridostigmine Bromide Tablets 60 mg because stability testing showed out-of-specification results.

    Product
    Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-914-2013·2013-08-28

    Bracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure

    Bracco Diagnostics Inc is recalling Tagitol V Barium Sulfate Suspension Lot #65846 because samples failed viscosity specifications.

    Product
    Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-890-2013·2013-08-21

    Medi-First First Aid Kits Recalled Due to Stability Testing Failures

    Total Resources International is voluntarily recalling Medi-First 61 Piece First Aid Kits because Benzalkonium Chloride failed stability testing.

    Product
    Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-889-2013·2013-08-21

    3M Tekk First Aid Kits Recalled for Stability Testing Failures

    Total Resources Int'l is voluntarily recalling 3M Tekk Industrial/Construction First Aid Kits due to stability testing failures of Benzalkonium Chloride.

    Product
    3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-891-2013·2013-08-21

    Total Resources International Recalls 326-Piece First Aid Kits Due to Stability Failures

    Total Resources International is voluntarily recalling 326-piece first aid kits because the active ingredient Benzalkonium Chloride failed stability testing.

    Product
    (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-807-2013·2013-07-24

    Bayer Recalls Medroxyprogesterone Acetate API Due to Stability Failures

    Bayer HealthCare Pharmaceuticals Inc. is recalling 194.62 kg of Medroxyprogesterone acetate API because it failed stability specifications for particle size.

    Product
    Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-603-2013·2013-06-26

    Hi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution

    Hi-Tech Pharmacal is recalling specific lots of HydrOXYzine Hydrochloride Oral Solution because the product failed stability testing and may be subpotent.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-604-2013·2013-06-26

    Sheffield Triple Antibiotic Ointment Recalled for Stability Failures

    Faria Limited LLC is recalling Dr. Sheffield's Triple Antibiotic Ointment because it failed stability specifications and could not meet shelf-life requirements.

    Product
    Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-451-2013·2013-05-29

    Lloyd Inc. Recalls Levothroid Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets due to cGMP deviations and stability failures. The recall covers specific lots distributed nationwide and to Puerto Rico.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-444-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Failures

    Lloyd Inc. of Iowa is recalling 5.7 million Thyro-Tab tablets because stability failures in previous lots make it impossible to verify the quality of the current lots.

    Product
    Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-433-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Failures

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab tablets due to cGMP deviations and stability failures. The product was distributed to Forest Laboratories for repackaging.

    Product
    Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-443-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab 0.175 mg tablets due to cGMP deviations and stability failures. The product was distributed to Forest Laboratories for repackaging.

    Product
    Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-450-2013·2013-05-29

    Lloyd Inc. Recalls Levothroid Tablets Due to Stability Failures

    Lloyd Inc. of Iowa is recalling Levothroid tablets due to cGMP deviations and stability failures in previous lots.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-438-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab tablets due to cGMP deviations and stability failures. The product was repackaged by Forest Laboratories and distributed nationwide.

    Product
    Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-434-2013·2013-05-29

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets due to cGMP deviations and insufficient stability data.

    Product
    Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-439-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling 7.6 million Thyro-Tab tablets due to cGMP deviations and stability failures. The product was distributed nationwide and to Puerto Rico.

    Product
    Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-445-2013·2013-05-29

    Lloyd Inc. of Iowa Recalls Levothroid Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling Levothroid tablets due to cGMP deviations and insufficient stability data. The recall covers 142,103 bottles distributed nationwide and to Puerto Rico.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-440-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab 0.125 mg tablets due to cGMP deviations and insufficient stability data.

    Product
    Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide