Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.
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. According to the rubric, FDA Class II recalls with potential for serious injury (such as lack of sterility assurance in injectable drugs) are rated as Severe (4), particularly when no explicit 'no illness' statement is provided to cap the score at 3.
Plain-English summary
Promise Pharmacy, LLC is recalling 416 vials of Ipamorelin, 9 mg injection, Rx Only. The recall was initiated because the product lacks sterility assurance. The affected lots are 07132018@5, 07302018@32, 09182018@7, and 10192018@2, with expiration dates ranging from January 9, 2019, to April 17, 2019.
The recalled product was distributed nationwide in the United States. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these vials.
Consumers and healthcare providers should stop using the affected lots of Ipamorelin and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ipamorelin, 9 mg 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
- 416
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 (4)
- Lots: 07132018@5 BUD: 1/9/2019
- 07302018@32 BUD: 1/26/2019
- 09182018@7 BUD: 3/17/2019
- 10192018@2 BUD: 4/17/2019
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