CLASS I Drug recall · Reported 12 Aug 2020 · FDA Enforcement Report
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial recalled
Mylan Institutional is recalling Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 7 Jul 2020 and the FDA has classified it as Class I.
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-1484-2020
- FDA event ID
- 85956
- Recalling firm
- Mylan Institutional, Rockford, IL
- Brand
- Daptomycin
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Jul 2020
- FDA classified
- 4 Aug 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Jul 2020 | Recall initiated by company | |
| 4 Aug 2020 | Classified by FDA | +28 days |
| 12 Aug 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #: 7605112, Exp 10/2021
Where was it sold?
USA 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Daptomycin recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg recalled | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg recalled | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| 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 |