CLASS III Drug recall · Reported 6 Jan 2021 · FDA Enforcement Report
Recalled product recalled by Strides Pharma
Strides Pharma is recalling Recalled product, distributed in Pennsylvania. The recall was initiated on 22 Dec 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-0180-2021
- FDA event ID
- 87027
- Recalling firm
- Strides Pharma, East Brunswick, NJ
- Brand
- Tacrolimus
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Dec 2020
- FDA classified
- 30 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 22 Dec 2020 | Recall initiated by company | |
| 30 Dec 2020 | Classified by FDA | +8 days |
| 6 Jan 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Moisture Limits
Product as listed by the FDA
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Where it was distributed
PA
Questions about this recall
Is Recalled product recalled?
Yes. Strides Pharma recalled Recalled product on 22 Dec 2020. The recall is Class III and its status is Terminated. Recall number D-0180-2021.
Why was it recalled?
Failed Moisture Limits
Which lots are affected?
Lot 7242728A; June 2023
Where was it sold?
PA
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 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 Strides Pharma
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets 90 mg recalled by Strides PharmaCinacalcet | Strides Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Methoxsalen Capsules, USP 10mg recalled by Strides PharmaMethoxsalen | Strides Pharma | 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 II | Tacrolimus Capsules, USP, 5 mg 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 | Tacrolimus Capsules, USP 5mg recalled by Mylan PharmaceuticalsTacrolimus | Mylan Pharmaceuticals | Other | Nationwide |