CLASS II ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
Cinacalcet Tablets, 30 mg recalled by Strides Pharma
Strides Pharma is recalling Cinacalcet Tablets, 30 mg, distributed nationwide in the US. The recall was initiated on 7 Oct 2026 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-0079-2027
- FDA event ID
- 100087
- Recalling firm
- Strides Pharma, Bridgewater, NJ
- Brand
- Cinacalcet
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2026
- FDA classified
- 26 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Oct 2026 | Recall initiated by company | |
| 26 Oct 2026 | Classified by FDA | +19 days |
| 28 Oct 2026 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed dissolution specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Failed dissolution specifications
Which lots are affected?
Lot # 7717825A, Expiry: 11/30/2028.
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 3 Nov 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 14| 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 Cinacalcet recalls
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |