Recalls by year
15
18
20
21
22
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2025DrugsFDA
Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/
Hazard: Failed Stability Specifications: Observed OOS results: eg results for colour index
October 12, 2022DrugsFDA
CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos
Hazard: Lack of Assurance of Sterility: environmental monitoring failure.
October 5, 2022DrugsFDA
CIPLA recalls Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe
Hazard: Lack of Assurance of Sterility
September 14, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cip
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
September 14, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
August 17, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., Ind
Hazard: Lack of Assurance of Sterility: Complaints received of defective container closure.
July 27, 2022DrugsFDA
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limite
Hazard: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
July 21, 2021DrugsFDA
CIPLA recalls Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufact
Hazard: CGMP Deviations
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
January 6, 2021DrugsFDA
CIPLA recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by
Hazard: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
December 23, 2020DrugsFDA
CIPLA recalls Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa
Hazard: cGMP deviations: Vials may not be sealed correctly affecting sterility.
December 26, 2018DrugsFDA
Cipla Limited recalls Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Man
Hazard: Failed Dissolution Specifications.
May 20, 2015DrugsFDA
Cipla Limited recalls Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indu
Hazard: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.