CLASS I Drug recall · Reported 15 May 2019 · FDA Enforcement Report
Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalled
Par Pharmaceutical is recalling Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials, distributed nationwide in the US. The recall was initiated on 30 Apr 2019 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-1293-2019
- FDA event ID
- 82680
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Manufacturer
- Par Health USA, LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Apr 2019
- FDA classified
- 22 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Apr 2019 | Recall initiated by company | |
| 15 May 2019 | Published in enforcement report | +15 days |
| 22 May 2019 | Classified by FDA | +7 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; glass fragment observed in one vial of reconstituted product
Product as listed by the FDA
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
Where it was distributed
nationwide
Questions about this recall
Is Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalled?
Yes. Par Pharmaceutical recalled Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials on 30 Apr 2019. The recall is Class I and its status is Terminated. Recall number D-1293-2019.
Why was it recalled?
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Which lots are affected?
AD812, exp 9/2020
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 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 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.
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Other Mycophenolate Mofetil recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil | VistaPharm | Other | Nationwide |