RecallRadar

FDA Drug recall D-1111-2015

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC…

On 2015-06-10 the FDA classified a Class II recall of Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC… by Mylan Lab, citing failed Dissolution Specifications: Low out of specification dissolution results.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1111-2015
ClassificationClass II
Statusterminated
Initiated2015-05-20
Published2015-06-10
Last updated2026-09-13 11:51 UTC
CompanyMylan Lab
DistributionUS

Product

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.

Reason

Failed Dissolution Specifications: Low out of specification dissolution results.

Identifiers

upc303784201787
code_infoLot #: 3059043, Exp 08/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1111-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.