CLASS III Drug recall · Reported 1 Apr 2020 · FDA Enforcement Report
Tacrolimus Capsules, USP 5mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Tacrolimus Capsules, USP 5mg, distributed nationwide in the US. The recall was initiated on 23 Mar 2020 and the FDA has classified it as Class III.
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-1057-2020
- FDA event ID
- 85273
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Tacrolimus
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Mar 2020
- FDA classified
- 24 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 23 Mar 2020 | Recall initiated by company | |
| 24 Mar 2020 | Classified by FDA | +1 day |
| 1 Apr 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Product as listed by the FDA
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Which lots are affected?
Lot # 3105410, 3106268, Exp 9/2020
Where was it sold?
U.S.A. 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | 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 |