Par Pharmaceutical Mycophenolate Mofetil for Injection Recall

Why it was recalled

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

Product description

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

Lot numbers, UPCs & expiration codes

AD812, exp 9/2020

Where it was sold

nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1293-2019
Classification: Class I
Status: Terminated
Recall initiated: Apr 30, 2019
FDA report date: May 15, 2019
Quantity: 4506 packs
Recall type: Voluntary: Firm initiated
Recalling firm: Par Pharmaceutical, Inc.

Original FDA data

Every field from FDA enforcement report D-1293-2019, exactly as published.

Show all FDA fields

City: Chestnut Ridge
State: NY
Status: Terminated
Country: United States
Event ID: 82680
Address: 1 Ram Ridge Rd
Code information: AD812, exp 9/2020
Postal code: 10977-6714
Report date: May 15, 2019
Product type: Drugs
Recall number: D-1293-2019
Classification: Class I
Recalling firm: Par Pharmaceutical, Inc.
Product quantity: 4506 packs
Termination date: Jun 20, 2023
Reason for recall: Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: nationwide
Recall initiation date: Apr 30, 2019
Initial firm notification: Letter
Center classification date: May 22, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1293-2019, published May 15, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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