CLASS III Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report

Meclizine Hydrochloride Tablets recalled by Par Pharmaceutical

Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets USP, distributed nationwide in the US. The recall was initiated on 26 Oct 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) 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, Expiry: OCT 2015; Lot #: 25787901, Expiry: NOV 2016; Lot #: 26074701, Expiry: JAN 2017; Lot #: 26259701, Expiry: MAR 2017; Lot #: 26575801, Expiry: JUN 2017; Lot #: 26579002, Expiry: JUN 2017; Lot #: 26682801, Expiry: SEP 2017; Lot #: 26682901, Expiry: SEP 2017; Lot #: 26731702, Expiry: NOV 2017; Lot #: 25960301, Expiry: NOV 2017; Lot #: 26764801, Expiry: MAR 2018.

Quantity recalleda) 387,100 Bottles; b) 63,572 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0234-2016
FDA event ID: 72476
Recalling firm: Par Pharmaceutical, Spring Valley, NY
Classification: Class III
Status: Terminated
Recall initiated: 26 Oct 2015
FDA classified: 13 Nov 2015
Reported: 25 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

26 Oct 2015	Recall initiated by company
13 Nov 2015	Classified by FDA	+18 days
25 Nov 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Which lots are affected?

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, Expiry: OCT 2015; Lot #: 25787901, Expiry: NOV 2016; Lot #: 26074701, Expiry: JAN 2017; Lot #: 26259701, Expiry: MAR 2017; Lot #: 26575801, Expiry: JUN 2017; Lot #: 26579002, Expiry: JUN 2017; Lot #: 26682801, Expiry: SEP 2017; Lot #: 26682901, Expiry: SEP 2017; Lot #: 26731702, Expiry: NOV 2017; Lot #: 25960301, Expiry: NOV 2017; Lot #: 26764801, Expiry: MAR 2018.

Where was it sold?

U.S. Nationwide including Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72476

Reported	Class	Recall	Company	Reason	Where
25 Nov 2015	CLASS III	Meclizine Hydrochloride Tablets recalled by Par Pharmaceutical	Par Pharmaceutical	Potency & Assay	Nationwide

More recalls from Par Pharmaceutical

All 17

Reported	Class	Recall	Company	Reason	Where
2 Sep 2020Drug	CLASS II	BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled	Par Pharmaceutical	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS II	Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical	Par Pharmaceutical	Potency & Assay	NY
25 Mar 2020Drug	CLASS III	PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone	Par Pharmaceutical	Other	Nationwide
19 Feb 2020Drug	CLASS III	Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical	Par Pharmaceutical	Labeling Errors	Nationwide
15 May 2019Drug	CLASS I	Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil	Par Pharmaceutical	Particulate Matter	Nationwide

Other Meclizine recalls

All 12

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
15 Jun 2022Drug	CLASS II	Meclizine Hydrochloride Tablets, USP, 25 mg cartons recalledMeclizine Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
13 Oct 2021Drug	CLASS II	Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Packaging Defects	NJ
24 Feb 2021Drug	CLASS II	Meclizine HCl Tablets, USP, 25 mg recalled by Wilshire Pharmaceuticals	Wilshire Pharmaceuticals	Potency & Assay	FL, TX
24 Feb 2021Drug	CLASS II	Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals	Wilshire Pharmaceuticals	Potency & Assay	FL, TX