Cipla recalls
15 federal recalls on file, showing the 10 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Cipla and put it in plain English.
Recent recalls
Cipla USA fosfomycin granules recalled for failed impurity specificationsCipla USA is recalling one lot of Fosfomycin Tromethamine Granules for Oral Solution due to failed quality testing for impurities and degradation. The affected lot (5KA0405, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.
ModerateFDAOct 14, 2026
- Cipla Cinacalcet tablets recalled for impurity risk
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.
ModerateFDAJul 8, 20263 products
- Cipla cinacalcet tablets recalled for N-nitroso impurity above limit
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain higher-than-acceptable levels of a chemical impurity called N-Nitroso Cinacalcet. The affected tablets were distributed nationwide. This is a manufacturing quality issue; no injuries have been reported.
ModerateFDAApr 22, 20263 products
- Cipla lanreotide injection recalled for sterility assurance concern
Cipla is recalling two versions of its lanreotide injection, 120 mg/0.5 mL pre-filled syringes, sold nationwide. The recall was prompted by an FDA observation at the contract manufacturing site about visual inspection procedures, so the product cannot be assured to be sterile. No injuries have been reported.
ModerateFDAApr 15, 20262 products
- Cipla USA nilotinib capsules recalled for failed appearance tests
Cipla USA is recalling specific lots of Nilotinib 150 mg capsules because testing found the capsules did not meet appearance and description standards after six months of storage. The affected lots are 5GJ0220, 5GJ0221, and 5GJ0222, with expiration date 04/30/2027. No injuries have been reported.
ModerateFDAMar 11, 20262 products
- Cipla diclofenac sodium gel recalled for failed pH specifications
Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.
ModerateFDAJan 28, 2026
- Stop using Cipla Lanreotide Injection
Cipla USA is recalling certain pre-filled syringes of Lanreotide Injection 120 mg because they may contain particulate matter (small particles) in the solution. The affected syringes have specific lot numbers and expiration dates between October 2026 and March 2027. No injuries have been reported so far.
ModerateFDAJan 21, 2026
- Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDADec 17, 20253 products
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Failed stability specifications: Out of specification for hardness test
FDADec 17, 20252 products
- Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Failed Stability Specifications: Observed OOS results: eg results for colour index
FDADec 10, 2025