Par Pharmaceutical Mycophenolate Mofetil Injection Recall: Particulate Matter Risk
Par Pharmaceutical recalls Mycophenolate Mofetil injection vials due to glass fragments found in one vial after reconstitution. Affected patients should contact their healthcare provider for guidance.
Use caution until it’s fixed
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Contact the company
What happened, in plain English
Par Pharmaceutical is recalling Mycophenolate Mofetil injection vials because glass fragments were found in one vial after reconstitution. This could cause serious injury if injected. Patients should not use the recalled vials and contact their doctor for alternatives. Read more at govinfonow.com/recall/38869-par-pharmaceutical-mycophenolate-mofetil-injection-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38869-par-pharmaceutical-mycophenolate-mofetil-injection-recall-particulate-matter-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1293-2019
Cite this page
“Par Pharmaceutical Mycophenolate Mofetil Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38869-par-pharmaceutical-mycophenolate-mofetil-injection-recall-particulate-matter-risk. Based on FDA recall #D-1293-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1293-2019%22&limit=1).
Why it’s dangerous
Glass fragments can be injected into the body, causing injury or infection. The hazard was observed in one vial after reconstitution, but the risk is not confirmed for all vials.
Who’s affected
Patients prescribed Mycophenolate Mofetil injection by a doctor. Those using the recalled vials are at risk of injury from glass fragments.
How to tell if you have this one
Check for the product name 'Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only'. The NDC code is 342023-172-044 and it was distributed by Par Pharmaceutical.
- Brand
Par Pharmaceutical- Category
Drug
What to do — step by step
Contact Healthcare Provider
Patients should contact their doctor to discuss alternative treatments and whether they have the recalled vials.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1293-2019 (April 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1293-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.