Cefepime for Injection Recalled Due to Lack of Sterility Assurance
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' Lack of sterility assurance in injectable medications presents significant potential harm, but no illnesses or injuries are mentioned in the source text.
Plain-English summary
Astral SteriTech Private Ltd. is recalling all lots of Cefepime for Injection, USP 1 gram per vial (101,550 vials total) distributed nationwide in the United States. The product is manufactured for Civica Inc. and carries NDC 72572-057-10.
The recall was initiated due to lack of assurance of sterility. Sterility is critical for injectable medications, as non-sterile products could introduce harmful microorganisms into patients. All affected lots remain within their expiration dates.
Patients who have received this medication should contact their healthcare provider immediately for guidance. Healthcare facilities should remove affected vials from inventory and follow recall instructions for proper handling and return.
The recalled product
- Product
- Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 101,550
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)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. 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 52 products in this recall →Related recalls
Same manufacturer · Astral SteriTech Private Ltd.
See all →- HighCeftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24
- HighCeftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-05-24
- HighAmpicillin and Sulbactam Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-24
- HighPiperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-05-24
- HighPiperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue
FDA (Drugs) · 2023-05-24
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
- HighCefepime injectable antibiotic bags recalled due to sterility concerns
FDA (Drugs) · 2023-02-22
- HighCeftazidime Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- SevereCaraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-07-02
- HighNafcillin for Injection recalled nationwide for lack of sterility assurance
FDA (Drugs) · 2023-05-31
- HighCefoxitin injectable bags recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-02-22
- SevereSentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03