CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Daptomycin for Injection, 500 mg per vial, packaged as-dose vial recalled
PFIZER is recalling Daptomycin for Injection, 500 mg per vial, packaged as-dose vial per, distributed nationwide in the US. The recall was initiated on 28 Jun 2018 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-1023-2018
- FDA event ID
- 80399
- Recalling firm
- PFIZER, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jun 2018
- FDA classified
- 2 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Jun 2018 | Recall initiated by company | |
| 2 Aug 2018 | Classified by FDA | +35 days |
| 8 Aug 2018 | 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
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Is Daptomycin for Injection, 500 mg per vial, packaged as-dose vial per recalled?
Yes. PFIZER recalled Daptomycin for Injection, 500 mg per vial, packaged as-dose vial per on 28 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-1023-2018.
Why was it recalled?
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Which lots are affected?
Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 21 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 PFIZER
All 126| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ 1 mg/mL) recalled by PFIZER | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Daptomycin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Daptomycin for Injection 350 mg/vial recalled by Accord HealthcareDaptomycin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Daptomycin for Injection 500 mg per vial, Single-dose vial recalledDaptomycin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS I | Daptomycin for Injection 350 mg/vial-dose vial recalled | Accord Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial recalledDaptomycin | Mylan Institutional | Particulate Matter | Nationwide |