Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Summary
The FDA issued a Class II for Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by Cipla USA, Inc.. Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI)..
Details
Source
Drug Recall
External ID
D-0661-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02
Lot/Code Info: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
Quantity Affected: 31,824 bottles
Reason for Recall
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-29
Company
Warren, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Cipla USA, Inc. has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0661-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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