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OFFICIAL-SOURCE RECALL · AUSTRALIA

Movicol Lemon & Lime 30s, Movicol Chocolate 30s, Movicol Junior Recall: Classification Class III Reason for

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryAustraliaPublishedAugust 19, 2026Last updatedAugust 19, 2026Official source last checkedAugust 26, 2026 at 7:44 PM UTC

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Is your product affected?

Brand
See official notice
Product
Movicol Lemon & Lime 30s, Movicol Chocolate 30s, Movicol Junior Flavour Free 30s
Manufacturer
See official notice
Lot number
numbers, 445603, 454784, 478815
Batch number
numbers, 445603, 454784, 478815
Date code
dates
Expiration date
dates

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Classification Class III Reason for the Action Norgine conducted an investigation into MOVICOL products manufactured using the single-shot campaign filling process utilising residual bulk material which remains in the manufacturing line when an Intermediate Bulk Container (IBC) is changed. The investigation identified that in a limited number of batches the product has been manufactured with residual bulk material which was later deemed out-of-specification. Norgine can confirm that there is no evidence of a patient safety or efficacy concern associated with this problem. A medical assessment of each out-of-specification blended bulk result concluded that the potential impact on patients would be negligible, taking into account the well-established efficacy and safety profile of macrogol 3350. Instructions for Customers/Users Customers are to: - Inspect inventory and take a photo of the affected stock on hand. - Destroy the affected stock to prevent further use. - Provide the photo evidence to Norgine for credit. Action Commencement Date 19/08/2026 Responsible Entity Norgine Pty Ltd

Hazard

Classification Class III Reason for the Action Norgine conducted an investigation into MOVICOL products manufactured using the single-shot campaign filling process utilising residual bulk material which remains in the manufacturing line when an Intermediate Bulk Container (IBC) is changed. The investigation identified that in a limited number of batches the product has been manufactured with residual bulk material which was later deemed out-of-specification. Norgine can confirm that there is no evidence of a patient safety or efficacy concern associated with this problem. A medical assessment of each out-of-specification blended bulk result concluded that the potential impact on patients would be negligible, taking into account the well-established efficacy and safety profile of macrogol 3350. Instructions for Customers/Users Customers are to: - Inspect inventory and take a photo of the affected stock on hand. - Destroy the affected stock to prevent further use. - Provide the photo evidence to Norgine for credit. Action Commencement Date 19/08/2026 Responsible Entity Norgine Pty Ltd

Official recall notice

Movicol Lemon & Lime 30s, Movicol Chocolate 30s, Movicol Junior Flavour Free 30s

Agency: Therapeutic Goods Administration

Official publication date: August 19, 2026

Read the official AU_TGA_DRAC recall notice →

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