Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle,… was recalled on June 29, 2026 in cooperation with the U.S. Food and Drug Administration because cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI)..
Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Units affected: N/A
Where it was sold: USA Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Cipla USA, Inc.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
Be the first to know when products like this are recalled. Free weekly digest, unsubscribe anytime.