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.

26–50 of 66

  • ModerateFDA (Drugs)·D-0452-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0034-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0077-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2017·2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 25 syringes of morphine sulfate 2 mg/mL due to stability data that does not support the expiry date, posing a risk of potential loss of potency.

    Product
    morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2017·2016-10-19

    Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0090-2017·2016-10-19

    Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0052-2017·2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0038-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 616 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0064-2017·2016-10-19

    Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 300 syringes of lidocaine HCl 1% because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0083-2017·2016-10-19

    Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Concerns

    Pharmedium Services, LLC is recalling specific lots of neostigmine methylsulfate syringes because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0037-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns

    Pharmedium Services, LLC is recalling 53,357 syringes of fentanyl citrate injection because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0058-2017·2016-10-19

    Pharmedium Recalls Labetalol HCl Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 969 syringes of labetalol HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1159-2016·2016-07-13

    Cantrell Drug Recalls Heparin Sodium Syringes Due to Stability Data Issues

    Cantrell Drug Company is recalling 352 syringes of Heparin Sodium 0.5 USP UNITS/mL because stability data does not support the expiration date.

    Product
    HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0840-2016·2016-05-18

    Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.

    Product
    Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2016·2016-04-13

    Meditech Formula 3 Injection Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 3 Injection vials because the active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0598-2016·2016-02-03

    Pharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.

    Product
    Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0605-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 378 units of Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers lots expiring up to November 17, 2015.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0597-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2016·2016-02-03

    Pharmakon Recalls Morphine Sulfate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling 525 syringes of Morphine Sulfate because stability data does not support the expiration dates.

    Product
    Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0606-2016·2016-02-03

    Pharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. All lots expiring up to 11/17/2015 are affected.

    Product
    Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2016·2016-02-03

    Pharmakon Recalls Rocuronium Syringes Due to Stability Data Concerns

    Pharmakon Pharmaceuticals is recalling 5,875 units of Rocuronium 10 mg/mL syringes because stability data does not support the expiration dates.

    Product
    Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2016·2016-02-03

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Stability Data Issues

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because stability data does not support the expiration dates. The recall covers 7,100 units distributed nationwide.

    Product
    Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide