CLASS II Drug recall · Reported 10 Jun 2015 · FDA Enforcement Report
Mycophenolic Acid Delayed-release Tablets, 180 mg recalled by Mylan Lab
Mylan Lab is recalling Mycophenolic Acid Delayed-release Tablets, 180 mg, distributed nationwide in the US. The recall was initiated on 20 May 2015 and the FDA has classified it as Class II.
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-1111-2015
- FDA event ID
- 71218
- Recalling firm
- Mylan Lab, Canonsburg, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2015
- FDA classified
- 29 May 2015
- Reported
- 10 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 May 2015 | Recall initiated by company | |
| 29 May 2015 | Classified by FDA | +9 days |
| 10 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Low out of specification dissolution results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Low out of specification dissolution results.
Which lots are affected?
Lot #: 3059043, Exp 08/16
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other Mycophenolic Acid recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg recalledMycophenolic Acid | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolic Acid DR, Tablet, 180 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |