Franck's Lab Recalls Sermorelin Acetate Due to Sterility Concerns
Franck's Lab Inc. is recalling Sermorelin Acetate products because FDA sampling found microorganisms 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 a lack of assurance of sterility in sterile human drugs, which poses a significant risk of infection or serious injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 63 units of Sermorelin Acetate products, including lyophilized kits and vials, as well as Sermorelin Acetate/GHRP 2,6 combinations. The recall covers sterile human drugs 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 finding indicates a lack of assurance of sterility for the affected products.
The affected products were distributed nationwide and in several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED…
- Category
- Drug — Sterile Human Drugs
- Affected units
- 63
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 →- 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 Lab Recalls Sterile Ceftazidime Ophthalmic Products Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Dapiprazole Ophthalmic Products Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Cefazolin Sterile Drugs Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Aminophylline Injectable Due to Sterility Concerns
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Ophthalmic Drugs Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Gentamicin Drugs Due to Microbial Contamination
FDA (Drugs) · 2012-08-22