Hazard

Stability Data recalls

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

What the numbers show

Total: 38
Critical: 0
Severe: 1
Most recent: 2018-03-21

Of the 38 stability data 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 (3%) 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 data 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.

26–38 of 38

ModerateFDA (Drugs)·D-0116-2018·2017-12-27
Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues
Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL syringes because stability data does not support the expiry dates. The recall affects 4,800 syringes distributed nationwide to hospitals.
Product
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2017·2017-05-10
Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data
Smith & Nephew is recalling 1,416 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0609-2016·2016-02-03
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. The recall covers all lots expiring through November 17, 2015.
Product
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 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-0603-2016·2016-02-03
Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL because stability data does not support the expiration dates.
Product
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0607-2016·2016-02-03
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. The recall covers all lots expiring through November 17, 2015.
Product
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 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-0604-2016·2016-02-03
Pharmakon Recalls Lidocaine HCI Injectable Syringes Due to Stability Data
Pharmakon Pharmaceuticals is recalling Lidocaine HCI 2% injectable syringes because stability data does not support the expiration dates.
Product
Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0588-2016·2016-02-03
Pharmakon Recalls Ephedrine Sulfate Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL injectable syringes because stability data does not support the expiration dates.
Product
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0602-2016·2016-02-03
Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL because stability data does not support the expiration dates.
Product
Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0590-2016·2016-02-03
Pharmakon Recalls Phenylephrine Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling Phenylephrine injectable syringes because stability data does not support the expiration dates.
Product
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0600-2016·2016-02-03
Pharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 600 syringes of Ketamine 100 mg/mL because stability data does not support the expiration dates.
Product
Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0595-2016·2016-02-03
Pharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
Pharmakon Pharmaceuticals is recalling 665 syringes of Midazolam (PF) because stability data does not support the expiration dates. The recall is nationwide.
Product
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-929-2015·2015-04-29
Attix Pharmaceuticals Recalls Ticarcillin Sodium/Potassium Clavulanate API Due to Stability Data Issues
Attix Pharmaceuticals is recalling Ticarcillin Sodium/Potassium Clavulanate API because stability data does not support the printed expiry dates for lots distributed between 2012 and 2015.
Product
Ticarcillin Sodium/Potassium Clavulanate (30:1) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1452-2014·2014-07-30
Estee Lauder Recalls DENBLAN Toothpaste Due to Stability Data Issues
Estee Lauder Inc is recalling 3,791 tubes of DENBLAN Anticavity Fluoride Toothpaste because stability data does not support the product's expiry date.
Product
DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
Category
Drug
Distribution
Distributed nationwide