The Recall Desk
LowFDA (Drugs)·D-0323-2020·Announced 2019-11-20

CVS Motion Sickness Tablets Recalled for Subpotent Drug Levels

Sato Pharmaceutical is recalling CVS Motion Sickness Fast Melting tablets because they may contain less than the labeled amount of meclizine hydrochloride.

What this means for you

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

Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a minor labeling/potency error rather than a contamination or safety defect.

Plain-English summary

Sato Pharmaceutical Inc. is voluntarily recalling CVS Motion Sickness Fast Melting (meclizine hydrochloride) 25 mg tablets. The recall was initiated because the product was found to be subpotent, meaning it may contain less than the labeled amount of the active ingredient. The affected product is sold in 12-count boxes with NDC 59779-534-01 and UPC 050428345535.

The recall covers 210,744 units distributed nationwide within the United States, Guam, and Saipan. Specific lots affected include TXWP and TXTP (expiring July 2020), AXTZ (expiring March 2021), AXNP (expiring July 2021), AXBC (expiring October 2021), and ZXWW (expiring December 2021). The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.

Consumers who have purchased these specific lots should check their medication packaging for the lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
CVS MOTION SICKNESS FAST MELTING (MECLIZINE HYDROCHLORIDE)
Brand
CVS MOTION SICKNESS FAST MELTING
Affected units
210,744

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 (11)

  • Lot #: TXWP
  • TXTP
  • Exp. date Jul 2020
  • AXTZ
  • Exp. date Mar 2021
  • AXNP
  • Exp. date Jul 2021
  • AXBC
  • Exp. date Oct 2021
  • ZXWW
  • Exp. date Dec 2021

UPCs (2)

  • 0050428473290
  • 050428345535

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Sato Pharmaceutical Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →