Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Hydromorphone Mixtures
Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found 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 involves sterile intrathecal drugs with confirmed microbial and fungal contamination, which poses a significant risk of serious infection or injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of six sterile intrathecal drug products containing bupivacaine and hydromorphone. The affected products include various concentrations and volumes, such as 15mg/40mg/ml in 40ml vials and 7.5mg/20mg/ml in 40ml vials. A total of 15 units were distributed nationwide and to several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
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 who receive these intrathecal injections. The distribution period for the recalled products was between November 21, 2011, and May 21, 2012.
Healthcare providers and patients should stop using the affected products immediately. Patients who have received these injections should contact their healthcare provider for evaluation. The recall covers specific prescription numbers listed in the official notice, including N0408787, N0390587, and others.
The recalled product
- Product
- BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML…
- Affected units
- 15
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 →- SevereGreenwich Rx Recalls Glutathione Injection Due to Microbial Contamination
FDA (Drugs) · 2026-10-28
- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- 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
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- 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 Ophthalmic Drugs Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Verapamil Injectable Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereRecall of Mepivacaine Injectable Due to Sterility Assurance Failure
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Lidocaine and Epinephrine Injectable Drugs
FDA (Drugs) · 2012-08-22