Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in an injectable drug) are classified as Severe (Score 4), as they are not explicitly Class I but involve significant risk.
Plain-English summary
Promise Pharmacy, LLC is voluntarily recalling Epithalon, 15mg injection, Rx Only. The recall is being conducted because of a lack of sterility assurance in the product. The affected product consists of 30 vials per package.
The recall covers two specific lots: Lot 09212018@11 with a beyond-use date of 12/20/2018, and Lot 11132018@4 with a beyond-use date of 2/11/2019. These products were distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected Epithalon injections and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 30
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 (2)
- Lots: 09212018@11 BUD: 12/20/2018
- 11132018@4 BUD: 2/11/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC 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 51 products in this recall →Related recalls
Same manufacturer · Promise Pharmacy, LLC
See all →- SevereMIC+Methyl B12 Injection Recalled for Lack of Processing Controls
FDA (Drugs) · 2021-09-22
- SeverePromise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SeverePromise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SeverePromise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- SeverePromise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighEpithalon injection recalled from one lot for lack of sterility assurance
FDA (Drugs) · 2025-10-15
- HighProgesterone Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- SeverePharmakon Recalls Propofol Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMIC+Methyl B12 Injection Recalled for Lack of Processing Controls
FDA (Drugs) · 2021-09-22
- SevereAlprostadil Injectable Recall: Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- LowPromise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate
FDA (Drugs) · 2018-10-31