CLASS II Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report
etomidate injection, USP, 2 mg/mL recalled by Agila Specialties Private
Agila Specialties Private is recalling etomidate injection, USP, 2 mg/mL, distributed nationwide in the US. The recall was initiated on 14 Feb 2014 and the FDA has classified it as Class II.
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-1225-2014
- FDA event ID
- 67580
- Recalling firm
- Agila Specialties Private, Bangalore, Karnataka, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Feb 2014
- FDA classified
- 8 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Feb 2014 | Recall initiated by company | |
| 8 Apr 2014 | Classified by FDA | +53 days |
| 16 Apr 2014 | 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
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Product as listed by the FDA
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is etomidate injection, USP, 2 mg/mL recalled?
Yes. Agila Specialties Private recalled etomidate injection, USP, 2 mg/mL on 14 Feb 2014. The recall is Class II and its status is Terminated. Recall number D-1225-2014.
Why was it recalled?
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Which lots are affected?
Lot #: a) 5000983, 5000986, Exp 08/14; 5001023, Exp 09/14; b) 5000927, 5000931, 5000936, 5000942, 06/14; 5001012, 5001040, Exp 09/14; 5001071, Exp 10/14
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other Etomidate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Etomidate Injection, USP 20 mg/ (2mg/mL) Single-Dose Vial recalled | Heritage Pharmaceuticals | Potency & Assay | Nationwide |