Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns
Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of microorganisms and fungal growth in a sterile product poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of specific Budesonide nasal irrigation solutions. The affected products are Budesonide (P.F) Nasal Irrigation 0.5mg/500ml Solution (1000 ml) and Budesonide (P.F) Nasal Irrigation 0.6mg/50ml Solution (1500 ml). The recall covers two different units associated with prescription numbers 0390774 and 0392517.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This finding indicates a lack of assurance of sterility for the products distributed during the period from November 21, 2011, to May 21, 2012.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Consumers who possess these specific prescription numbers should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining a replacement.
The recalled product
- Product
- BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
- Category
- Drug — Sterile Compounded Drug
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Rx #'s: 0390774
- 0392517
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 100 products in this recall →Related recalls
Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab
See all →- SevereFranck's Lab Recalls Sterile Methylcobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereRecall of Sterile Ophthalmic Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15