Guardian Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
Guardian Pharmacy Services is recalling 300 syringes of Fentanyl Citrate 50 mcg/mL in Texas due to a lack of sterility assurance.
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 rating under the rubric for significant injury risks or hospitalization potential, specifically due to the lack of sterility assurance in an injectable medication.
Plain-English summary
Guardian Pharmacy Services is recalling 300 2-mL syringes of Fentanyl Citrate 50 mcg/mL. The product was compounded by Guardian Pharmacy Services and distributed in Texas. The specific lot number is 58854:42, with a use-by date of 06/28/2018.
The recall was initiated because of a lack of sterility assurance. This means the product may not be sterile, which poses a risk of infection if administered.
Consumers and healthcare providers who have this specific lot of Fentanyl Citrate should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Injectable
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 (1)
- Lots: 58854:42 Use By: 06/28/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services 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 23 products in this recall →Related recalls
Same manufacturer · Guardian Pharmacy Services
See all →- SevereGuardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
- SevereGuardian Pharmacy Recalls Phenol 6% Injection Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
- SevereGuardian Pharmacy Recalls Morphine Sulfate CADD Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
- SevereGuardian Pharmacy Recalls Cefazolin Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
- SevereGuardian Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-08-15
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
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
Similar recalls
- SeverePharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereBanner Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-01
- SeverePharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighFDA Recalls Fentanyl Syringes for Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighFentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure
FDA (Drugs) · 2023-10-11