FDAMay 20, 2015drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Dissolution Specifications: Low out of specification dissolution results.
What to do
FDA enforcement status: Terminated
Brands named
mylan labmylan
UPCs
303784201787
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.2026-02-24
- FDABD Kiestra" ReadA; Catalog No.: 446948.2026-02-06
- FDAThyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-022026-01-16
- FDAAloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 553442025-09-25
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- FDAMai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: Dietary supplement f...2025-08-26
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