Drug recall: Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe

FDA enforcement event 90864 · Class II · initiated 15 Sep 2022 · status Terminated · terminated 10 Jan 2024

DrugVoluntary: Firm initiated1 product recordWarren, NJ

CIPLA (Warren, NJ) initiated this drug recall on 15 Sep 2022; FDA lists 1 product record under event 90864, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 10 Jan 2024. Initiation: voluntary: firm initiated. CIPLA has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CIPLA, Warren, NJ.

Reason for recall

"Lack of Assurance of Sterility"

Distribution

"Nationwide in the USA and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1545-2022	Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.	641,160 ampules	Class II	Terminated	5 Oct 2022

Context

65%of 2022 drug events are Class II325 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for CIPLA

Initiated	Product (first record)	Type	Class	Records
29 Sep 2022	Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos	Drug	Class II	1
22 Aug 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton	Drug	Class II	2
2 Aug 2022	Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., Ind	Drug	Class II	1
14 Jul 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limite	Drug	Class II	1
10 Jun 2021	Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufact	Drug	Class II	1
17 Dec 2020	Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by	Drug	Class II	3
14 Dec 2020	Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa	Drug	Class II	1

All 8 events for CIPLA

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Jan 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.