Cinacalcet Hydrochloride Tablets — Class II drug recall D-0451-2026
Ongoing recall by Cipla USA, Inc., reported 2026-04-22, distributed nationwide. CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
| Recall number | D-0451-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2026-03-16 |
| Classified | 2026-04-10 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 63,192 bottles |
| Reason classes | cgmp |
| NDC | 69097-0410, 69097-0410-02, 69097-0411, 69097-0411-02, 69097-0412, 69097-0412-02 |
| Lot numbers | 4PB0224, 4PB0505, 4PB0506, 4PB0507, 5PB0564, APRIL-2027, MARCH-2026, SEPTEMBER-2026 |
Product
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Reason for recall
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0451-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.