Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.
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, which corresponds to a Severe severity score per the rubric for significant injury risks or hospitalization reports.
Plain-English summary
Promise Pharmacy, LLC is recalling Folic Acid, 5mg/ml injection, 10ml vials, Rx Only. The recall is being conducted because the product lacks sterility assurance.
The affected product is identified by Lot 10302018@8 with a Beyond Use Date of 12/14/2018. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Injectable Medication
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)
- Lot: 10302018@8
- BUD 12/14/2018
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 Epithalon Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
Same hazard · infection
See all →- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
Similar recalls
- SevereFolic Acid Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereRXQ Compounding Recalls Folic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- HighFolic Acid Injectable Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2022-07-20
- SevereNatures Pharmacy Recalls Folic Acid Injections Due to Sterility Concerns
FDA (Drugs) · 2014-03-12
- SevereKey Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- SevereMoses Lake Pharmacy Recalls Folic Acid Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2015-11-04