Aidarex Recalls Ceftriaxone for Injection Due to Manufacturing Deviations
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling Ceftriaxone for Injection USP, 250mg/vial, NDC 53217-0117-01. The product was manufactured by Lupin Limited India and packaged by Aidarex Pharmaceuticals. The recall involves Lot 47312-1, which expires in January 2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification (OOS) intermediate was identified in the subsequent processes used to manufacture the final active pharmaceutical ingredient (API).
The affected product was distributed in Indiana and Georgia. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 10
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#: 47312-1
- Exp 01/2018
Distribution
Related recalls
Same manufacturer · Aidarex Pharmaceuticals LLC
See all →- ModerateAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2018-05-23
- ModerateAidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures
FDA (Drugs) · 2017-11-01
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
Similar recalls
- LowLupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
FDA (Drugs) · 2016-06-08
- SevereLupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter
FDA (Drugs) · 2019-01-16
- SevereLupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter
FDA (Drugs) · 2019-01-16
- ModerateLupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records
FDA (Drugs) · 2019-01-23
- LowLupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations
FDA (Drugs) · 2016-06-08
- HighCeftriaxone for Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-24