CLASS III Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Ceftriaxone for Injection USP, 250mg/vial recalled
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250mg/vial, distributed in Georgia, Indiana. The recall was initiated on 1 Jun 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0974-2016
- FDA event ID
- 74316
- Recalling firm
- Aidarex Pharmaceuticals, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Jun 2016
- FDA classified
- 7 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 1 Jun 2016 | Recall initiated by company | |
| 7 Jun 2016 | Classified by FDA | +6 days |
| 15 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
Where it was distributed
IN, GA
Questions about this recall
Is Ceftriaxone for Injection USP, 250mg/vial recalled?
Yes. Aidarex Pharmaceuticals recalled Ceftriaxone for Injection USP, 250mg/vial on 1 Jun 2016. The recall is Class III and its status is Terminated. Recall number D-0974-2016.
Why was it recalled?
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Which lots are affected?
Lot#: 47312-1, Exp 01/2018
Where was it sold?
IN, GA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aidarex Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ferrous Sulfate recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Other | FL |
| Drug | CLASS III | Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | FL |
Other Ceftriaxone recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ceftriaxone for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP 250 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |