FDA Drug recall D-0907-2018

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b)…

FDA Drug
Class III
terminated
Published 2018-07-11

On 2018-07-11 the FDA classified a Class III recall of Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b)… by Lupin Somerset, citing labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0907-2018
Classification	Class III
Status	terminated
Initiated	2018-06-13
Published	2018-07-11
Last updated	2026-09-13 11:52 UTC
Company	Lupin Somerset
Distribution	US

Product

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716

Reason

Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.

Identifiers

code_info	a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, E… a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, Exp 3/20; S700228, Exp 4/20; S700304, Exp 5/20; S700510, Exp 7/20; S700780, Exp 10/20; S701063, S701112, Exp 12/20; S800170, Exp 2/21; S800349, Exp 3/21; S800366, Exp 4/21; S800453, Exp 5/21; b) M16560A, M16561A, M16562A, Exp 9/19; M16607A, Exp 11/19; S700202, Exp 4/20; S700415, Exp 6/20; S700511, Exp 7/20; S700752, Exp 9/20; S700902, Exp 10/20; S701119, Exp 12/20; S800097, Exp 2/21; S800296, S800306, Exp 3/21.

code_info

a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, E…

a) M16425A, Exp 06/18; M16463A, Exp 7/18; M16516A, Exp 8/19; M16605A, Exp 10/19; M17005A, Exp 1/20; S700119, S700157, Exp 3/20; S700228, Exp 4/20; S700304, Exp 5/20; S700510, Exp 7/20; S700780, Exp 10/20; S701063, S701112, Exp 12/20; S800170, Exp 2/21; S800349, Exp 3/21; S800366, Exp 4/21; S800453, Exp 5/21; b) M16560A, M16561A, M16562A, Exp 9/19; M16607A, Exp 11/19; S700202, Exp 4/20; S700415, Exp 6/20; S700511, Exp 7/20; S700752, Exp 9/20; S700902, Exp 10/20; S701119, Exp 12/20; S800097, Exp 2/21; S800296, S800306, Exp 3/21.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0907-2018%22

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