Mylan Lab Mycophenolic Acid Delayed-release Tablets Recall

Why it was recalled

Failed Dissolution Specifications: Low out of specification dissolution results.

Product description

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

Lot numbers, UPCs & expiration codes

Lot #: 3059043, Exp 08/16

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-1111-2015
Classification: Class II
Status: Terminated
Recall initiated: May 20, 2015
FDA report date: Jun 10, 2015
Quantity: 7,722 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Lab Inc

Original FDA data

Every field from FDA enforcement report D-1111-2015, exactly as published.

Show all FDA fields

City: Canonsburg
State: PA
Status: Terminated
Country: United States
Event ID: 71218
Address: 1500 Corporate Dr Ste 400
Code information: Lot #: 3059043, Exp 08/16
Postal code: 15317-8580
Report date: Jun 10, 2015
Product type: Drugs
Recall number: D-1111-2015
Classification: Class II
Recalling firm: Mylan Lab Inc
Product quantity: 7,722 bottles
Termination date: Oct 21, 2016
Reason for recall: Failed Dissolution Specifications: Low out of specification dissolution results.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
Distribution pattern: Nationwide
Recall initiation date: May 20, 2015
Initial firm notification: Letter
Center classification date: May 29, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1111-2015, published Jun 10, 2015. 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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