CLASS II Drug recall · Reported 18 May 2016 · FDA Enforcement Report
Brevibloc Double Strength Premixed Injection recalled
Baxter Healthcare is recalling Brevibloc Double Strength Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, distributed nationwide in the US. The recall was initiated on 12 Apr 2016 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-0852-2016
- FDA event ID
- 73812
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Brevibloc
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2016
- FDA classified
- 12 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Apr 2016 | Recall initiated by company | |
| 12 May 2016 | Classified by FDA | +30 days |
| 18 May 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: presence of atypical yellow discoloration of the solution .
Product as listed by the FDA
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Discoloration: presence of atypical yellow discoloration of the solution .
Which lots are affected?
Lot # C989954, Exp 9/17
Where was it sold?
Nationwide
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.
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Other Esmolol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Esmolol HCl 100 mg/ (10mg/ mL) Single Dose Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Esmolol HCl Injectable Solution 100 mg recalled by Advanced Pharma | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Esmolol HCl in all strengths, all doses, and all packaging recalled | Pharmedium Services | Sterility | Nationwide |
| Drug | CLASS II | Brevibloc Premixed Injection, Esmolol Hydrochloride recalledBrevibloc | Baxter Healthcare | Particulate Matter | Nationwide |