Cipla USA, Inc. recalls
Every recall we track for Cipla USA, Inc. — 24 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Cipla USA, Inc. more than doubled in 2025 (8, up from 3 in 2024). 8% rated “stop using now”.
All FDA recall records for Cipla USA, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 1 |
| 2024 | 0 | 1 | 2 | 0 | 3 |
| 2025 | 0 | 0 | 4 | 4 | 8 |
| 2026 (to date) | 1 | 0 | 6 | 5 | 12 |
Most common reasons for Cipla USA, Inc. recalls
What to do if you have a recalled Cipla USA, Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Cipla USA, Inc. recalls
14 shown- UnratedDrug
Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx
Cipla USA recalls specific lots of Fosfomycin Tromethamine Granules due to failed impurity specifications. Check your lot number and expiration date.
Cipla USASep 18, 2026 - Lower riskDrug
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Cipla USA recalls 30mg Cinacalcet tablets with N-nitroso-cinacalcet above safe daily intake levels. Consumers should contact Cipla for details on affected lots and return instructions.
CiplaJun 29, 2026 - Lower riskDrug
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Cipla USA recalls 30mg Cinacalcet tablets due to N-Nitroso contamination exceeding safe limits. Affected lots manufactured in India for US distribution. Consumers should contact Cipla for details.
CiplaMar 16, 2026 - Lower riskDrug
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by:
Cipla USA recalls Lanreotide Injection 120 mg/0.5 mL syringes due to potential contamination from inadequate visual inspection at manufacturing. This could lead to infections if used.
CiplaMar 13, 2026 - Lower riskDrug
Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India,
Cipla USA recalls 150mg Nilotinib capsules with stability concerns. Products may show appearance issues after 6 months. Check NDC 69097-031-74 for affected lots.
CiplaFeb 18, 2026 - Stop using nowDrug
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only,
Cipla USA recalls Lanreotide Injection 120 mg/0.5 mL syringes due to particulate matter. Affected lots expire through 2027. Stop using if you have these specific lot numbers.
CiplaJan 2, 2026 - UnratedDrug
Cipla USA, Inc. recalls Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine
Cipla USA recalls 1% Diclofenac Sodium Topical Gel due to failed pharmaceutical specifications. Consumers should check NDC 76282-103-39 and batch XHBG for affected units.
CiplaDec 22, 2025 - UnratedDrug
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10
Cipla USA recalls 90mg Cinacalcet tablets due to nitrosamine impurity exceeding safe limits. Patients should consult their doctor for alternatives.
CiplaNov 14, 2025 - Lower riskDrug
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen
Cipla USA recalls 1000mg Lanthanum Carbonate chewable tablets due to hardness test failure. This may affect tablet integrity and safety. Check your Rx-only medication packaging for the recall.
CiplaOct 24, 2025 - UnratedDrug
Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd,
Cipla USA recalls albuterol inhalers with potential particle size issues. This may affect stability and safety. Check your NDC 69097-142-60 lot 4IB0519 for affected units.
CiplaJul 24, 2025 - Lower riskDrug
Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured
Cipla USA recalls 0.5mg/2ml Budesonide inhaler ampules due to leakage and empty ampoules. Stop using if you have the specific batch.
Cipla USAJun 30, 2025 - Lower riskDrug
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Cipla USA recalls 1000mg Lanthanum Carbonate Chewable Tablets due to complaints of crushed and broken tablets. No remedy specified in official notice.
Cipla USAOct 23, 2024 - Use cautionDrug
Cipla USA, Inc. recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton
Cipla USA recalls unit-dose vials of Ipratropium Bromide and Albuterol Sulfate due to short fill complaints. Check your lot numbers for details.
Cipla USAMar 26, 2024 - Stop using nowDrug
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx
Cipla USA recalls Albuterol Sulfate Inhalation Aerosol due to defective containers that may be empty or leak. Check lot numbers and expiration dates.
Cipla USAJun 27, 2023
Cipla USA, Inc. recall questions
How many recalls has Cipla USA, Inc. had?
24 recalls from Cipla USA, Inc. are on record with U.S. safety agencies, from 2023–2026.
What is the most recent Cipla USA, Inc. recall?
Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx, dated Sep 18, 2026. Every Cipla USA, Inc. recall is listed on this page, newest first.
Why are Cipla USA, Inc. products recalled?
The most common reasons on record: Failed stability specifications: Out of specification for hardness test (2).
What should I do if I have a recalled Cipla USA, Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Cipla USA, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.