Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns
Promise Pharmacy is recalling 2,595 vials of HCG injections nationwide due to a lack of sterility assurance.
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 involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or injury.
Plain-English summary
Promise Pharmacy, LLC is recalling 2,595 vials of HCG (Human chorionic gonadotropin) 5,000 units injection. The product is prescription-only and was distributed nationwide in the USA. The recall is being conducted due to a lack of sterility assurance.
The affected lots include 06252018@1, 07132018@7, 07262018@2, 08212018@7, 08272018@2, and 09052018@2. These lots have best-use dates ranging from December 22, 2018, to February 28, 2019.
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
- HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,595
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)
- Lots: 06252018@1 BUD: 12/22/2018
- 07132018@7 BUD: 1/9/2019
- 07262018@2 BUD: 1/22/2019
- 08212018@7 BUD: 2/17/2019
- 08272018@2 BUD: 2/23/2019
- 09052018@2 BUD: 2/28/2019
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 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 Epithalon 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 →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15