Medications & Supplements/Over-the-Counter

LUPIN SOMERSET: Equate ClearLAX Laxative Recalled Due to Labeling Errors

Agency Publication Date: July 3, 2018

Summary

Lupin Somerset is recalling approximately 2.2 million bottles of Equate ClearLAX (polyethylene glycol 3350) powder for solution, an over-the-counter osmotic laxative. The recall was issued because the products were labeled with unfiled National Drug Code (NDC) numbers, meaning the identifier on the package does not match official regulatory records. These products were sold nationwide, specifically at Walmart, in 119 g and 238 g bottle sizes with various expiration dates ranging from 2018 to 2021. Consumers should check their containers for the affected lot numbers and contact a healthcare professional regarding their use.

Risk

The product labeling contains incorrect regulatory identifiers (NDC numbers), which can lead to confusion in tracking and identifying the medication. While the FDA classifies this as a low-risk labeling issue, it is a violation of labeling requirements; no injuries or adverse health effects have been reported.

What You Should Do

Check your medicine cabinet for Equate ClearLAX (polyethylene glycol 3350) powder in 119 g bottles (NDC 49035-312-07) or 238 g bottles (NDC 49035-312-08).
For 119 g bottles, identify if your lot number and expiration date matches any of the following: M16425A (Exp 06/18), M16463A (Exp 7/18), M16516A (Exp 8/19), M16605A (Exp 10/19), M17005A (Exp 1/20), S700119 or S700157 (Exp 3/20), S700228 (Exp 4/20), S700304 (Exp 5/20), S700510 (Exp 7/20), S700780 (Exp 10/20), S701063 or S701112 (Exp 12/20), S800170 (Exp 2/21), S800349 (Exp 3/21), S800366 (Exp 4/21), or S800453 (Exp 5/21).
For 238 g bottles, identify if your lot number and expiration date matches any of the following: M16560A, M16561A, or 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), or S800296 or S800306 (Exp 3/21).
Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and for instructions on how to handle affected bottles.
Return any unused, affected product to the place of purchase for a full refund or contact the manufacturer, Lupin Somerset, at 400 Campus Dr, Somerset, New Jersey for further instructions.
For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund available for unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution (119 g)

Model:

49035-312-07

Lot Numbers:

M16425A (Exp 06/18)

M16463A (Exp 7/18)

M16516A (Exp 8/19)

M16605A (Exp 10/19)

M17005A (Exp 1/20)

S700119 (Exp 3/20)

S700157 (Exp 3/20)

S700228 (Exp 4/20)

S700304 (Exp 5/20)

S700510 (Exp 7/20)

S700780 (Exp 10/20)

S701063 (Exp 12/20)

S701112 (Exp 12/20)

S800170 (Exp 2/21)

S800349 (Exp 3/21)

S800366 (Exp 4/21)

S800453 (Exp 5/21)

Date Ranges: Exp 06/18, Exp 7/18, Exp 8/19, Exp 10/19, Exp 1/20, Exp 3/20, Exp 4/20, Exp 5/20, Exp 7/20, Exp 10/20, Exp 12/20, Exp 2/21, Exp 3/21, Exp 4/21, Exp 5/21

Product: Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution (238 g)

Model:

49035-312-08

Lot Numbers:

M16560A (Exp 9/19)

M16561A (Exp 9/19)

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 (Exp 3/21)

S800306 (Exp 3/21)

Date Ranges: Exp 9/19, Exp 11/19, Exp 4/20, Exp 6/20, Exp 7/20, Exp 9/20, Exp 10/20, Exp 12/20, Exp 2/21, Exp 3/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80266

Status: Resolved

Manufacturer: LUPIN SOMERSET

Sold By: Walmart

Manufactured In: United States

Units Affected: 2,229,052 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medicine cabinet for Equate ClearLAX (polyethylene glycol 3350) powder in 119 g bottles (NDC 49035-312-07) or 238 g bottles (NDC 49035-312-08).

For 119 g bottles, identify if your lot number and expiration date matches any of the following: M16425A (Exp 06/18), M16463A (Exp 7/18), M16516A (Exp 8/19), M16605A (Exp 10/19), M17005A (Exp 1/20), S700119 or S700157 (Exp 3/20), S700228 (Exp 4/20), S700304 (Exp 5/20), S700510 (Exp 7/20), S700780 (Exp 10/20), S701063 or S701112 (Exp 12/20), S800170 (Exp 2/21), S800349 (Exp 3/21), S800366 (Exp 4/21), or S800453 (Exp 5/21).

For 238 g bottles, identify if your lot number and expiration date matches any of the following: M16560A, M16561A, or 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), or S800296 or S800306 (Exp 3/21).

Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and for instructions on how to handle affected bottles.

Return any unused, affected product to the place of purchase for a full refund or contact the manufacturer, Lupin Somerset, at 400 Campus Dr, Somerset, New Jersey for further instructions.

For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution (119 g)

Model:

49035-312-07

Lot Numbers:

M16425A (Exp 06/18)

M16463A (Exp 7/18)

M16516A (Exp 8/19)

M16605A (Exp 10/19)

M17005A (Exp 1/20)

S700119 (Exp 3/20)

S700157 (Exp 3/20)

S700228 (Exp 4/20)

S700304 (Exp 5/20)

S700510 (Exp 7/20)

S700780 (Exp 10/20)

S701063 (Exp 12/20)

S701112 (Exp 12/20)

S800170 (Exp 2/21)

S800349 (Exp 3/21)

S800366 (Exp 4/21)

S800453 (Exp 5/21)

Date Ranges: Exp 06/18, Exp 7/18, Exp 8/19, Exp 10/19, Exp 1/20, Exp 3/20, Exp 4/20, Exp 5/20, Exp 7/20, Exp 10/20, Exp 12/20, Exp 2/21, Exp 3/21, Exp 4/21, Exp 5/21

Product: Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution (238 g)

Model:

49035-312-08

Lot Numbers:

M16560A (Exp 9/19)

M16561A (Exp 9/19)

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 (Exp 3/21)

S800306 (Exp 3/21)

Date Ranges: Exp 9/19, Exp 11/19, Exp 4/20, Exp 6/20, Exp 7/20, Exp 9/20, Exp 10/20, Exp 12/20, Exp 2/21, Exp 3/21