Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Is Mycophenolate recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Mycophenolate (11 total). Check the affected lots below.
Most common reason: Labeling / mix-up (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mycophenolate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mycophenolate recalls in 2026
2 initiated in 2026, 11 in total — newest first
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
Class III · Low risk
Mycophenolate Mofetil for Oral Suspension
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class II · Moderate risk
Mycophenolate Mofetil active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Mycophenolate Mofetil
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg, NDC 16714058501, Pedigree: W003761, EXP: 6/26/2014.
Class II · Moderate risk
Mycophenolate Mofetil
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00004025901, Pedigree: AD49414_1, EXP: 5/17/2014.
Class II · Moderate risk
Mycophenolate Mofetil
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11, EXP: 5/17/2014.
Class II · Moderate risk
Mycophenolate Mofetil
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: W003213, EXP: 6/14/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011010, Pedigree: AD65317_1, EXP: 5/24/2014.
Class III · Low risk
CellCept (mycophenolate mofetil)
Short Fill: some bottles contained less than 120-count per labeled claim.
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