CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Prednisone Tablets USP, 20 mg recalled by Strides Pharma
Strides Pharma is recalling Prednisone Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 19 Jul 2022 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-1330-2022
- FDA event ID
- 90634
- Recalling firm
- Strides Pharma, East Brunswick, NJ
- Brand
- Prednisone
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2022
- FDA classified
- 9 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 19 Jul 2022 | Recall initiated by company | |
| 9 Aug 2022 | Classified by FDA | +21 days |
| 17 Aug 2022 | 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: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Product as listed by the FDA
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Where it was distributed
US Nationwide
Questions about this recall
Is Prednisone Tablets USP, 20 mg recalled?
Yes. Strides Pharma recalled Prednisone Tablets USP, 20 mg on 19 Jul 2022. The recall is Class II and its status is Terminated. Recall number D-1330-2022.
Why was it recalled?
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Which lots are affected?
Lot #: 7248988B, Exp 9/2023
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 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 Prednisone recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets, USP, 20 mg recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prednisone Tablets, USP 5 mg recalled by Lannett Company | Lannett Company | Other | Nationwide |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Prednisone Tablet recalled by Boehringer Ingelheim RoxanePrednisone | Boehringer Ingelheim Roxane | Labeling Errors | Nationwide |