The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0907-2018·Announced 2018-07-11

Equate ClearLAX Recalled for Unfiled NDC Numbers on Labeling

Lupin Somerset is recalling Equate ClearLAX laxative bottles due to unfiled NDC numbers on the labels. This is a Class III recall with no reported health risks.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error (unfiled NDC numbers) rather than a physical or chemical hazard.

Plain-English summary

Lupin Somerset is recalling 2,229,052 bottles of Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, an over-the-counter osmotic laxative. The product is distributed by Walmart Stores, Inc., and is available in 119 g and 238 g bottle sizes. The recall is nationwide.

The recall was initiated because a private label distributor noted unfiled National Drug Code (NDC) numbers on the product labels. This is a labeling issue classified as 'Not Elsewhere Classified.' The FDA has classified this as a Class III recall, which indicates that the product is not likely to cause adverse health consequences or death.

Consumers with this product should check the lot numbers and expiration dates listed in the recall notice to determine if their bottles are affected. Since this is a labeling error with no reported health hazards, consumers can return the product to the place of purchase for a refund or follow instructions from the manufacturer.

The recalled product

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
Manufacturer
LUPIN SOMERSET
Category
Drug — Over-the-Counter Laxative
Hazard
Affected units
2,229,052

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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