Red Mountain Compounding Recalls S-Phenol Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Phenol 6% Injection Solution because the product lacks assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Phenol 6% Injection Solution, prescription only, in 10ml glass vials. The recall is due to a lack of assurance of sterility in the product.
The affected product is distributed nationwide in the USA. Specific lots involved in the recall include S06242019DH@08 (expiration 9/24/19), S07242019DH@08 (expiration 10/24/19), and S07312019DH@03 (expiration 10/31/19).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.
- Category
- Drug — Injectable Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: S06242019DH@08
- Exp 9/24/19
- S07242019DH@08
- Exp 10/24/19
- S07312019DH@03
- Exp 10/31/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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 · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
See all →- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTestosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereRed Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
- SevereTEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29