CLASS II Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Tacrolimus Capsules, USP, 0.5 mg recalled by Sandoz
Sandoz is recalling Tacrolimus Capsules, USP, 0.5 mg, distributed nationwide in the US. The recall was initiated on 22 Oct 2013 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-383-2014
- FDA event ID
- 66531
- Recalling firm
- Sandoz, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2013
- FDA classified
- 20 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 22 Oct 2013 | Recall initiated by company | |
| 20 Dec 2013 | Classified by FDA | +59 days |
| 1 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Product as listed by the FDA
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Which lots are affected?
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Where was it sold?
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 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 4 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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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 |