Home / Recalls / Cipla USA, Inc. / D-0450-2026

D-0450-2026 Class II Ongoing

Recalled by Cipla USA, Inc. — Warren, NJ

Recall Details

Product Type
Drugs
Report Date
April 22, 2026
Initiation Date
March 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96,096 bottles

Product Description

Cinacalcet Hydrochloride Tablets, 60 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: 69097-411-02

Reason for Recall

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Distribution Pattern

Nationwide in the USA

Code Information

Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027

Other recalls by Cipla USA, Inc.

  • D-0449-2026 Class II — Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufac (March 16, 2026)
  • D-0451-2026 Class II — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufac (March 16, 2026)
  • D-0423-2026 Class II — Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single d (March 13, 2026)
  • D-0422-2026 Class II — Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 sa (March 13, 2026)
  • D-0382-2026 Class III — Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactur (February 18, 2026)
  • D-0381-2026 Class III — Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactur (February 18, 2026)
  • D-0290-2026 Class II — Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep sub (January 2, 2026)
  • D-0291-2026 Class III — Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT (December 22, 2025)
  • D-0226-2026 Class II — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufac (November 14, 2025)
  • D-0225-2026 Class II — Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufac (November 14, 2025)