Franck's Lab Recalls Sterile Tobramycin Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile tobramycin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a lack of assurance of sterility in injectable and ophthalmic products, which poses a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall involves nine different tobramycin-based products, including ophthalmic solutions, injectable solutions, and naso-nebulizer formulations.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk of infection to patients using the products.
The affected products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatments.
The recalled product
- Product
- TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB…
- Category
- Drug — Sterile Compounded Drugs
- Affected units
- 13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 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 98 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 →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereFranck's Lab Recalls Sterile Gentamicin Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Clindamycin Eye and Injectable Products
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Bevacizumab Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Amphotericin B Drugs Due to Contamination
FDA (Drugs) · 2012-08-22