CLASS II ONGOING Drug recall · Reported 1 Mar 2023 · FDA Enforcement Report
Tacrolimus Capsules, USP, 5 mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Tacrolimus Capsules, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 8 Feb 2023 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-0330-2023
- FDA event ID
- 91661
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Tacrolimus
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Feb 2023
- FDA classified
- 21 Feb 2023
- Reported
- 1 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 8 Feb 2023 | Recall initiated by company | |
| 21 Feb 2023 | Classified by FDA | +13 days |
| 1 Mar 2023 | 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 Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Product as listed by the FDA
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Tacrolimus Capsules, USP, 5 mg recalled?
Yes. Dr. Reddy's Laboratories recalled Tacrolimus Capsules, USP, 5 mg on 8 Feb 2023. The recall is Class II and its status is Ongoing. Recall number D-0330-2023.
Why was it recalled?
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Which lots are affected?
Lot # C2106445; Exp. 03/2024
Where was it sold?
Nationwide in the USA
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 21 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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Tacrolimus recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Prograf (tacrolimus) capsules, USP, 5 mg recalled by Astellas Pharma USPrograf | 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 III | Tacrolimus Ointment, 1%, For Dermatological Use Only recalledTacrolimus | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS III | Recalled product recalled by Strides PharmaTacrolimus | Strides Pharma | Other | PA |
| Drug | CLASS III | Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus | Mylan Pharmaceuticals | Other | Nationwide |