CLASS II Drug recall · Reported 5 Dec 2012 · FDA Enforcement Report
Tacrolimus Capsules 0.5 mg recalled by Mylan
Mylan is recalling Tacrolimus Capsules 0.5 mg. The recall was initiated on 29 Jun 2012 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-066-2013
- FDA event ID
- 62454
- Recalling firm
- Mylan, Caguas, PR
- Brand
- Tacrolimus
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2012
- FDA classified
- 26 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Jun 2012 | Recall initiated by company | |
| 26 Nov 2012 | Classified by FDA | +150 days |
| 5 Dec 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
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
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Where it was distributed
Natiowide
Questions about this recall
Why was it recalled?
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Which lots are affected?
Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Where was it sold?
Natiowide
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.
More recalls from Mylan
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 180 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Mylan | Mylan | Other | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 100 mg recalled by Mylan | Mylan | Packaging Defects | Nationwide |
Other Tacrolimus recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalledAstagraf Xl | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS I | Prograf (tacrolimus) capsules, USP, 0.5 mg recalledPrograf | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS II | Tacrolimus Capsules, USP 1mg recalled by Dr. Reddy's LaboratoriesTacrolimus | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Tacrolimus Capsules, USP, 0.5 mg recalled by Dr. Reddy's LaboratoriesTacrolimus | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS III | Tacrolimus Ointment, 0.1%, For Dermatological Use Only recalledTacrolimus | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |