Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures
Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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 the hazard involves a lack of assurance of sterility in intrathecal drugs, which carries a significant risk of serious injury or hospitalization due to infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling four sterile intrathecal drug products containing bupivacaine and morphine sulfate. The affected products are Bupivacaine/Morphine Sulfate, P.F. 2.5mg/10mg/ml Intrathecal 40 ml; Bupivacaine/Morphine Sulfate, P.F. 7.5mg/25mg/ml Intrathecal 20 ml; Bupivacaine/Morphine Sulfate, P.F. 7.5mg/50mg/ml Intrathecal 18 ml; and Bupivacaine/Morphine Sulfate, P.F. 7.5mg/50mg/ml Intrathecal 35 ml. The recall covers 16 units distributed between November 21, 2011, and May 21, 2012.
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 receiving the drugs.
The products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Specific prescription numbers associated with the recalled units are listed in the source data. Healthcare providers and patients should stop using these products and contact the manufacturer or FDA for further instructions.
The recalled product
- Product
- BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Intrathecal
- Affected units
- 16
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 →- 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 Compounding Lab Recalls Morphine Sulfate Injectable Products
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Injectable Drugs Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Lidocaine and Epinephrine Injectable Drugs
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 Levofloxacin Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22