The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0234-2016·Announced 2015-11-25

Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

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 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 III, which indicates a low probability of adverse health consequences, aligning with the Moderate severity level for minor labeling or specification errors without reported harm.

Plain-English summary

Par Pharmaceutical Inc. is recalling Meclizine Hydrochloride Tablets USP, 25 mg, in 100-count and 1000-count bottles. The recall was initiated because the product failed to meet impurities/degradation specifications, specifically being out of specification for impurities.

The affected product is prescription-only and was distributed nationwide, including Puerto Rico. The recall includes specific lot numbers with expiration dates ranging from October 2015 to March 2018. The total quantity involved is 387,100 bottles of the 100-count size and 63,572 bottles of the 1000-count size.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on alternative treatments or returns.

The recalled product

Product
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Manufacturer
Par Pharmaceutical Inc.
Category
Drug — Prescription Medication
Hazard

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) Lot #: 25552101
  • Expiry: AUG 2016
  • Lot#: 25712701
  • Expiry: SEP 2016
  • Lot #: 25787902
  • Expiry: NOV 2016
  • Lot #: 26074601
  • Expiry: JAN 2017
  • Lot #: 26259801
  • Expiry: APR 2017
  • Lot #: 26220001
  • Expiry: MAR 2017
  • Lot #: 26579001
  • Expiry: JUN 2017
  • Lot #: 26731801
  • Expiry: NOV 2017. b) Lot #: 24502301
  • Expiry: OCT 2015
  • Lot #: 24505901
  • Lot #: 25787901
  • Lot #: 26074701

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 2 recalled by Par 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 2 products in this recall →

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