CLASS III Drug recall · Reported 16 Dec 2015 · FDA Enforcement Report

Meclizine Hydrochloride Tablets, 25 mg recalled

Golden State Medical Supply is recalling Meclizine Hydrochloride Tablets, 25 mg, distributed nationwide in the US. The recall was initiated on 25 Nov 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.

Quantity recalleda) 737 Bottles; b) 3863 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-0510-2016
FDA event ID: 72733
Recalling firm: Golden State Medical Supply, Camarillo, CA
Classification: Class III
Status: Terminated
Recall initiated: 25 Nov 2015
FDA classified: 4 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay

Timeline

25 Nov 2015	Recall initiated by company
4 Dec 2015	Classified by FDA	+9 days
16 Dec 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, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

Where it was distributed

U.S. Nationwide

Nationwide

Questions about this recall

Is Meclizine Hydrochloride Tablets, 25 mg recalled?

Yes. Golden State Medical Supply recalled Meclizine Hydrochloride Tablets, 25 mg on 25 Nov 2015. The recall is Class III and its status is Terminated. Recall number D-0510-2016.

Why was it recalled?

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

Which lots are affected?

a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.

Where was it sold?

U.S. Nationwide

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

More recalls from Golden State Medical Supply

All 54

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26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalledCarbamazepine	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
17 Jun 2026Drug	CLASS II	Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin	Golden State Medical Supply	Potency & Assay	CA
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
24 Dec 2025Drug	CLASS II	Baclofen Tablets USP, 10 mg recalled by Golden State Medical SupplyBaclofen	Golden State Medical Supply	Other	Nationwide

Other Meclizine recalls

All 12

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 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, 5 mg recalled by Wilshire Pharmaceuticals	Wilshire Pharmaceuticals	Potency & Assay	FL, TX