Cipla recalls

Cipla appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-10.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd
  FDA Drug · Class II · 2025-12-10 · Cipla
  Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index
• Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch,…
  FDA Drug · Class II · 2022-10-12 · Cipla
  Reason: Lack of Assurance of Sterility: environmental monitoring failure.
• Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Su…
  FDA Drug · Class II · 2022-10-05 · Cipla
  Reason: Lack of Assurance of Sterility
• Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 762…
  FDA Drug · Class II · 2022-09-14 · Cipla
  Reason: 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.
• Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07…
  FDA Drug · Class II · 2022-09-14 · Cipla
  Reason: 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.
• Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured fo…
  FDA Drug · Class II · 2022-08-17 · Cipla
  Reason: Lack of Assurance of Sterility: Complaints received of defective container closure.
• Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, V…
  FDA Drug · Class II · 2022-07-27 · Cipla
  Reason: 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.
• Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA,…
  FDA Drug · Class II · 2021-07-21 · Cipla
  Reason: CGMP Deviations
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurku…
  FDA Drug · Class II · 2021-01-06 · Cipla
  Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurku…
  FDA Drug · Class II · 2021-01-06 · Cipla
  Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurku…
  FDA Drug · Class II · 2021-01-06 · Cipla
  Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
• Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Ja…
  FDA Drug · Class II · 2020-12-23 · Cipla
  Reason: cGMP deviations: Vials may not be sealed correctly affecting sterility.
• Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd
  FDA Drug · Class II · 2018-12-26 · Cipla
  Reason: Failed Dissolution Specifications.
• Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only
  FDA Drug · Class III · 2015-05-20 · Cipla
  Reason: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.