Franck's Lab Recalls Sterile Epinephrine Products Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile epinephrine products distributed between November 2011 and May 2012 because FDA sampling found microorganisms 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 the hazard involves a lack of assurance of sterility in injectable and ophthalmic drugs, which carries 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 33 units of sterile epinephrine products. The affected products include various formulations of Epinephrine 1:1000 Injectable and Epinephrine HCl Solution 1% Ophthalmic. These products 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 using the products. The distribution period for the recalled items was between November 21, 2011, and May 21, 2012.
Healthcare providers and patients should stop using these products immediately. Specific prescription numbers associated with the recall are listed in the official FDA notice. Consumers should contact their healthcare provider for guidance on alternative treatments and to report any adverse reactions.
The recalled product
- Product
- EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS…
- Category
- Drug — Sterile Injectable
- Affected units
- 33
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 Lab Recalls Sterile Lidocaine and Epinephrine Injectable Drugs
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Phenylephrine Injectable Drugs Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Mitomycin Injectable Drugs Due to Contamination
FDA (Drugs) · 2012-08-22
- SevereFranck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures
FDA (Drugs) · 2012-08-22
- SevereFranck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
FDA (Drugs) · 2012-08-22
- SevereRecall of Mepivacaine Injectable Due to Sterility Assurance Failure
FDA (Drugs) · 2012-08-22