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.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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 2/5 (Moderate).
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…
- 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 →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- SevereMylan Recalls Gemcitabine Injection Vials Due to Particulate Matter
FDA (Drugs) · 2015-08-26
- HighAminophylline Injection Recalled for Particulate Matter
FDA (Drugs) · 2022-10-12
- CriticalMethotrexate Injection Recalled Due to Presence of Particulate Matter
FDA (Drugs) · 2015-08-19
- LowExela Pharma Recalls Potassium Acetate Injection Vials Due to Short Fill
FDA (Drugs) · 2020-09-23
- ModerateDrug Recall: Eptifibatide Injection Due to Failed Degradation Specifications
FDA (Drugs) · 2024-06-26
- HighInjectable Acyclovir Sodium Recalled for Particulate Matter Contamination
FDA (Drugs) · 2023-01-11