CLASS III Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report

Equate ClearLAX, Polyethylene Glycol 3350 Powder recalled

Lupin Somerset is recalling Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, distributed nationwide in the US. The recall was initiated on 13 Jun 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) 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.

Quantity recalled2,229,052 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0907-2018
FDA event ID: 80266
Recalling firm: Lupin Somerset, Somerset, NJ
Classification: Class III
Status: Terminated
Recall initiated: 13 Jun 2018
FDA classified: 3 Jul 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Stomach & Acid Reflux Medication

Timeline

13 Jun 2018	Recall initiated by company
3 Jul 2018	Classified by FDA	+20 days
11 Jul 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Stores named: Walmart

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lupin Somerset

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1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 15 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide