The Recall Desk

Hazard

Stability Concern recalls

20 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
20
Critical
0
Severe
1
Most recent
2024-01-03

Of the 20 stability concern recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) 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 concern 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.

1–20 of 20

  • HighFDA (Drugs)·D-0170-2024·2024-01-03

    Low-dose aspirin recall due to improper storage temperature conditions

    Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.

    Product
    ASPIRIN — ASPIRIN (ASPIRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0179-2024·2024-01-03

    Enoxaparin Sodium Injection recalled due to improper storage conditions

    Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.

    Product
    ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2024·2024-01-03

    Propranolol Hydrochloride 20 mg Tablets Recalled for Temperature Storage Deviations

    Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.

    Product
    PROPRANOLOL HYDROCHLORIDE — PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0857-2023·2023-06-07

    Amantadine Hydrochloride Oral Solution Recalled Due to CGMP Deviations

    Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution (50mg/5mL) nationwide due to inability to complete required stability studies following the firm's closure, resulting in manufacturing quality deviations.

    Product
    Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0830-2023·2023-06-07

    Naloxone Injection Recall Due to Manufacturing Process Deviations

    Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.

    Product
    Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0834-2023·2023-06-07

    Oxcarbazepine Oral Suspension Recalled Due to Manufacturing and Stability Deviations

    Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.

    Product
    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0784-2023·2023-06-07

    FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures

    Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.

    Product
    Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0810-2023·2023-06-07

    Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1404-2022·2022-08-31

    Dr. Scholls Wart and Callus Remover Products Recalled for Storage Deviation

    Family Dollar Stores is recalling Dr. Scholls Clear Away Wart Remover, Callus Remover Pads, and Corn Removers distributed April 30 to June 10, 2022, due to improper storage conditions.

    Product
    DR SCHOLLS CLR AWAY LIQ WART REMVR 20CT SKU 998384 DR SCHOLLS CALLUS REMOVER PADS 4CT SKU 998431 DR SCHOLLS CORN REMOVERS 9CT SKU 998403 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2022·2022-08-17

    FDA Recalls Dakin's Solution Due to Storage Condition Deviations

    McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.

    Product
    DAKINS QUARTER — DAKINS QUARTER (SODIUM HYPOCHLORITE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1321-2022·2022-08-17

    FDA Recalls Pataday Eye Allergy Drops Due to Storage Deviations

    Mckesson Medical-Surgical is recalling Pataday Once Daily Relief eye drops nationwide because the products were stored outside label specifications. No illnesses have been reported.

    Product
    PATADAY ONCE DAILY RELIEF — PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1103-2022·2022-06-15

    Ondansetron Tablets Recalled for Temperature Exposure During Storage

    McKesson is recalling Ondansetron Hydrochloride 8 mg tablets distributed nationwide due to temperature abuse during storage that may affect medication stability. Patients should contact their pharmacy or doctor.

    Product
    ONDANSETRON HYDROCHLORIDE — ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1028-2022·2022-06-15

    FDA Recalls Betamethasone Dipropionate Cream for Temperature-Abuse Storage Deviations

    McKesson Medical-Surgical is recalling Betamethasone Dipropionate Cream USP 0.05% due to temperature-abuse cGMP deviations. The FDA Class II recall affects nationwide distribution.

    Product
    Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1069-2022·2022-06-15

    Medroxyprogesterone acetate injection recalled due to temperature abuse manufacturing deviation

    McKesson Medical-Surgical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) due to temperature abuse during manufacturing. The affected vials were distributed nationwide; patients should contact their healthcare provider.

    Product
    Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0848-2022·2022-05-11

    Lidocaine Hydrochloride Topical Solution Recalled for Manufacturing Quality Deviations

    McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution due to manufacturing deviations related to discontinuation of the stability study program. Approximately 81,757 bottles distributed nationwide are affected.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0771-2022·2022-04-20

    Econazole Nitrate Cream Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Econazole Nitrate Cream 1% due to CGMP deviations. The manufacturer discontinued its stability study program; affected lots were distributed in California and Florida.

    Product
    Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1160-2016·2016-07-13

    Cantrell Drug Recalls Heparin Sodium Syringes Due to Stability Data Concerns

    Cantrell Drug Company is recalling 4,170 syringes of Heparin Sodium in 0.45% Sodium Chloride because stability data does not support the expiration date.

    Product
    HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1035-2015·2015-05-20

    Nadolol 10 mg/1 mL Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Nadolol 10 mg/1 mL Suspension due to lack of assurance of sterility and stability data supporting the expiry date.

    Product
    Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0214-2015·2014-11-26

    Siemens ADVIA Centaur Cleaning Solution Recalled for Stability Concerns

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.

    Product
    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2159-2012·2012-08-15

    Roche Recalls Cobas KRAS Mutation Test Kits Due to Stability Concerns

    Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.

    Product
    Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from form
    Category
    Medical Device
    Distribution
    0 states