CLASS III Drug recall · Reported 16 Dec 2015 · FDA Enforcement Report
Meclizine Hydrochloride Tablets, 12.5 mg recalled
Golden State Medical Supply is recalling Meclizine Hydrochloride Tablets, 12.5 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
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-0509-2016
- 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
- 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, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Which lots are affected?
Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.
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 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 72733This product is part of a recall event; the main page for the event is Meclizine Hydrochloride Tablets, 25 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Meclizine Hydrochloride Tablets, 25 mg recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
More recalls from Golden State Medical Supply
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
Other Meclizine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP, 25 mg cartons recalledMeclizine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Packaging Defects | NJ |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 25 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |