Etomidate Injection (Agila) – Particulate Matter Risk (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Agila Specialties Private Ltd.
Lot Codes / Batch Numbers
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
Products Sold
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
Agila Specialties Private Ltd. is recalling etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (ND due to Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or exp. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026