Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated May 15, 2023 (3 years ago)

Ceftriaxone for Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42

Affected NDC 66794-0212-42

Compare with the code on your package — it is the most precise check available.

Drug: Ceftriaxone

Recalling firm
Astral SteriTech Private Ltd.
NDC code
66794-212-42
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0612-2023 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Ceftriaxone recalls

See all

Other recalls by Astral SteriTech Private Ltd.

All 2023 recalls