Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets for Impurities
Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride Tablets, 25 mg, packaged in 100-count and 1,000-count bottles. The recall involves specific lots of the medication, which is a prescription-only drug manufactured by Par Pharmaceuticals Companies Inc. and packaged by GSMS Incorporated.
The recall was initiated because the tablets failed impurities/degradation specifications, specifically being out of specification for impurities. The affected products were distributed nationwide in the United States.
Consumers who have these specific lots of Meclizine Hydrochloride Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on returning the product or obtaining a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Golden State Medical Supply 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 #: 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
- Lot #: GS005908
- Expiry: Jun-17
- Lot #: GS006088
- Lot #: GS006254
- Expiry: Sep-17
- Lot #: GS007345
- Lot #: GS007664
- Lot #: GS007803
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Golden State Medical Supply 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 →Related recalls
Same manufacturer · Golden State Medical Supply Inc.
See all →- SevereGolden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
FDA (Drugs) · 2026-09-09
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModeratePar Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures
FDA (Drugs) · 2015-11-25
- LowPar Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities
FDA (Drugs) · 2015-11-25
- ModerateMylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures
FDA (Drugs) · 2015-11-25
- ModerateParoxetine 40 mg tablets recalled for out-of-specification impurities
FDA (Drugs) · 2023-12-06
- SevereGolden State Medical Supply Recalls Omeprazole Capsules Due to Impurities
FDA (Drugs) · 2021-03-31
- ModerateParoxetine 20 mg Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06