Agila Recalls Etomidate Injection Due to Particulate Matter and Labeling Issues
Agila Specialties Private Ltd. is recalling etomidate injection vials due to potential particulate matter and missing or illegible lot and expiry date labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential particulate matter and labeling errors without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Agila Specialties Private Ltd. is recalling specific lots of etomidate injection, USP, 2 mg/mL, distributed by Pfizer Labs. The recall involves 7,919 cartons of the medication, which was distributed nationwide and in Puerto Rico.
The recall was initiated due to the potential presence of small black particles in individual vials. Additionally, there is a potential for missing lot numbers and/or expiry dates on the outer cartons, as well as illegible or missing lot numbers and expiry dates on the individual vials.
Healthcare providers and patients should check their inventory for the affected NDC codes and lot numbers listed in the recall notice. If the product is found, it should be quarantined and not administered until further notice.
The recalled product
- 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-
- Manufacturer
- Agila Specialties Private Ltd.
- Category
- Drug — Injectable Medication
- Affected units
- 7,919
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 (14)
- Lot #: a) 5000983
- 5000986
- Exp 08/14
- 5001023
- Exp 09/14
- b) 5000927
- 5000931
- 5000936
- 5000942
- 06/14
- 5001012
- 5001040
- 5001071
- Exp 10/14
Distribution
Related recalls
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26