CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report

GSMS: Ranitidine Capsules 300 mg recalled by Golden State Medical Supply

Golden State Medical Supply is recalling GSMS: Ranitidine Capsules 300 mg, distributed in Arizona, Iowa, Massachusetts, Missouri. The recall was initiated on 6 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.

Quantity recalledN/A

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-0308-2020
FDA event ID: 84233
Recalling firm: Golden State Medical Supply, Camarillo, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2019
FDA classified: 10 Nov 2019
Reported: 20 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Stomach & Acid Reflux Medication

Timeline

6 Nov 2019	Recall initiated by company
10 Nov 2019	Classified by FDA	+4 days
20 Nov 2019	Published in enforcement report	+10 days

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

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.

Where it was distributed

AZ, IA, MA, MO

Arizona Iowa Massachusetts Missouri

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

Which lots are affected?

Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.

Where was it sold?

AZ, IA, MA, MO

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 84233

This product is part of a recall event; the main page for the event is GSMS: Ranitidine Capsules 150 mg recalled by Golden State Medical Supply.

Reported	Class	Recall	Company	Reason	Where
20 Nov 2019	CLASS II	GSMS: Ranitidine Capsules 150 mg recalled by Golden State Medical Supply	Golden State Medical Supply	Nitrosamine Impurity	4 states

More recalls from Golden State Medical Supply

All 55

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
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

Other Gsms: Ranitidine recalls

All 2

Reported	Class	Recall	Company	Reason	Where
20 Nov 2019Drug	CLASS II	GSMS: Ranitidine Capsules 150 mg recalled by Golden State Medical Supply	Golden State Medical Supply	Nitrosamine Impurity	4 states