The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0259-2021·Announced 2021-02-24

Wilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures

Wilshire Pharmaceuticals is recalling 3,592 bottles of Meclizine HCl 25 mg tablets because they failed dissolution specifications. The affected product was distributed in Florida and Texas.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential but not confirmed adverse health consequences.

Plain-English summary

Wilshire Pharmaceuticals, Inc. is recalling 3,592 bottles of Meclizine HCl Tablets, USP, 25 mg (NDC 52536-133-01). The recall was initiated because the product failed to meet dissolution specifications. The affected lots are 18030329, 18030330, and 18030331, all with an expiration date of 03/2021.

The recalled product was distributed in Florida and Texas. Meclizine HCl is a prescription medication used to treat motion sickness and dizziness. The product is manufactured in India for Wilshire Pharmaceuticals, Inc., located in Atlanta, Georgia.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
Manufacturer
Wilshire Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
35,928

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 (4)

  • Lot #: 18030329
  • 18030330
  • 18030331
  • Exp 03/2021.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Wilshire Pharmaceuticals 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 2 products in this recall →

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