CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Etomidate Injection, USP 20 mg/ (2mg/mL) Single-Dose Vial recalled
Heritage Pharmaceuticals is recalling Etomidate Injection, USP 20 mg/ (2mg/mL) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 15 Feb 2019 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-1065-2019
- FDA event ID
- 82198
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2019
- FDA classified
- 27 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Feb 2019 | Recall initiated by company | |
| 27 Mar 2019 | Classified by FDA | +40 days |
| 27 Mar 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug.
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
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug.
Which lots are affected?
Lot #: AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.
Where was it sold?
Nationwide within the United States
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 26 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 Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Etomidate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | etomidate injection, USP, 2 mg/mL recalled by Agila Specialties Private | Agila Specialties Private | Particulate Matter | Nationwide |
| Drug | CLASS II | Etomidate 0.2% (2mg/ML) Injectable (1 Product) recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |