Cipla recalls
20 official recalls and safety alerts involving Cipla since 2022-07, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cipla or the relevant agency.
- 2026-10-14
USCipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
Failed Impurities/Degradation Specifications
- 2026-07-08
- US
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for:…
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
- 2026-04-22
- US
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- 2026-04-15
- US
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- 2026-03-11
- US
Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for:…
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- 2026-01-28
- US
- 2026-01-21
- US
- 2025-12-17
- US
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- US
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals,…
Failed stability specifications: Out of specification for hardness test
- 2025-12-10
- US
Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule…
Failed Stability Specifications: Observed OOS results: eg results for colour index
- 2025-08-27
- US
Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ,…
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
- 2025-07-30
- US
Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd.…
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- 2024-11-20
- US
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- 2024-05-01
- US
Cipla USA, Inc. recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30…
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- 2023-07-19
- US
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured…
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- 2022-10-12
- US
CIPLA recalls 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,…
Lack of Assurance of Sterility: environmental monitoring failure.
FDA · DrugCIPLAProduct was distributed nationwide to distributors/wholesalers who may have…Official notice → - 2022-10-05
- US
- 2022-09-14
- US
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC…
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.
- 2022-08-17
- US
CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured…
Lack of Assurance of Sterility: Complaints received of defective container closure.
- 2022-07-27
- US
CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34,…
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.