Ceftriaxone Injectable Recalled Due to Lack of Sterility Assurance
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
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 is a Class II drug recall involving a risk-of-harm product—a sterile injectable lacking assurance of sterility poses a serious potential for harm. However, no illnesses or injuries have been reported, placing this in the High category per the rubric criterion for "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Ceftriaxone for Injection, USP 1 gram per vial is being recalled nationwide. Manufactured by Astral SteriTech Private Ltd. and distributed for Piramal Critical Care, the recall includes approximately 73,475 vials distributed within the United States. All affected lots are still within their expiration dates.
The recall was initiated due to lack of assurance of sterility. The manufacturer could not confirm that the vials meet the required sterility standards for injectable medications. As a sterile pharmaceutical product, ceftriaxone must meet strict sterility requirements to ensure patient safety.
Healthcare providers and institutions that received affected vials should cease use immediately. Patients and healthcare professionals with questions about affected medication should contact the manufacturer or their healthcare provider.
The recalled product
- Product
- Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Antibiotic Injection
- Affected units
- 73,475
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
- HighCeftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighCeftazidime Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- SeverePharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighPhenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
FDA (Drugs) · 2023-03-08
- HighNephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
- HighPhenylephrine HCl Injection Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-08