Stop using nowDrug recall · FDA · Published September 29, 2022
Cipla Arformoterol Inhaler Recall: Sterility Risk in Some Units
Cipla recalls certain batches of Arformoterol Tartrate Inhalation Solution due to environmental monitoring failure causing lack of sterility. This could lead to infections if used.
“Cipla Arformoterol Inhaler Recall: Sterility Risk in Some Units.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34311-cipla-arformoterol-inhaler-recall-sterility-risk-in-some-units. Based on FDA recall #D-1550-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1550-2022%22&limit=1).
Cipla recalled Arformoterol Tartrate Inhalation Solution due to a lack of assurance of sterility caused by an environmental monitoring failure, the FDA said on Sept. 29, 2022. The voluntary Class II recall involved 9,041 cartons distributed nationwide.
The recall addresses a lack of assurance of sterility resulting from an environmental monitoring failure, the FDA said.
Context
GovInfoNow's records show Cipla has 7 other recalls on record since Dec. 14, 2020. Other recent recalls of similar products include a Sept. 15, 2022 Budesonide Inhaler recall for lack of sterility risk, an Aug. 22, 2022 Difluprednate Eye Drops recall for contaminated drops, and an Aug. 2, 2022 Difluprednate Ophthalmic Emulsion recall for container closure defects. Additional recent recalls include a March 13, 2026 Lanreotide Injection recall for contamination risk due to sterility issues and a Oct. 31, 2025 Phytonadione Injectable Emulsion recall for stability issues.
How to tell if you have this one
Check the product label for the NDC codes 69097-168-48 or 69097-168-64. The vials were packaged in 5 x 2 mL vials per pouch and 12 x 5 vials per carton, with batch numbers IA10082-IA10086 (expiring 01/2023) or IA10122-IA10130 (expiring 02/2023).
Brand
Cipla
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the recalled Arformoterol Tartrate Inhalation Solution vials as they may contain contaminants that could cause infections.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1550-2022 (September 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1550-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.