CLASS II Drug recall · Reported 17 Jan 2024 · FDA Enforcement Report
Tacrolimus Capsules, USP 1mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Tacrolimus Capsules, USP 1mg, distributed nationwide in the US. The recall was initiated on 15 Dec 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-0219-2024
- FDA event ID
- 93622
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Tacrolimus
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Dec 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 15 Dec 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +21 days |
| 17 Jan 2024 | 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
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Product as listed by the FDA
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Which lots are affected?
Lot# C2307275; Exp. January 2026
Where was it sold?
US 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 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 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 0.75% 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 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, 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 |
| Drug | CLASS III | Strides Pharma products recalledTacrolimus | Strides Pharma | Other | PA |