CLASS II Drug recall · Reported 26 Oct 2022 · FDA Enforcement Report

Rifampin Capsules, USP, 300 mg recalled by Golden State Medical Supply

Golden State Medical Supply is recalling Rifampin Capsules, USP, 300 mg, distributed nationwide in the US. The recall was initiated on 6 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: a) GS041430, GS041941, Exp 1/31/2023; GS041315, GS042991, GS043027, GS043367, GS043501, GS044421, Exp 3/31/2023; b) GS041431, GS041799, GS042287, GS042414, GS042879, Exp: 1/31/2023; GS041316, GS042992, GS043368, GS043579, Exp 3/31/2023; c) GS041429, GS041877, Exp 1/31/2023; GS041317, GS043028, GS043366, GS044422, Exp 3/31/2023

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-0011-2023
FDA event ID: 90992
Recalling firm: Golden State Medical Supply, Camarillo, CA
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2022
FDA classified: 17 Oct 2022
Reported: 26 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity

Timeline

6 Oct 2022	Recall initiated by company
17 Oct 2022	Classified by FDA	+11 days
26 Oct 2022	Published in enforcement report	+9 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: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

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

Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.

Where it was distributed

USA nationwide

Nationwide

Questions about this recall

Why was it recalled?

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Which lots are affected?

Lot#: a) GS041430, GS041941, Exp 1/31/2023; GS041315, GS042991, GS043027, GS043367, GS043501, GS044421, Exp 3/31/2023; b) GS041431, GS041799, GS042287, GS042414, GS042879, Exp: 1/31/2023; GS041316, GS042992, GS043368, GS043579, Exp 3/31/2023; c) GS041429, GS041877, Exp 1/31/2023; GS041317, GS043028, GS043366, GS044422, Exp 3/31/2023

Where was it sold?

USA 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 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 90992

This product is part of a recall event; the main page for the event is Rifampin Capsules, USP, 150 mg recalled by Golden State Medical Supply.

Reported	Class	Recall	Company	Reason	Where
26 Oct 2022	CLASS II	Rifampin Capsules, USP, 150 mg recalled by Golden State Medical Supply	Golden State Medical Supply	Nitrosamine Impurity	Nationwide

More recalls from Golden State Medical Supply

All 55

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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 Rifampin recalls

All 21

Reported	Class	Recall	Company	Reason	Where
17 Apr 2024Drug	CLASS II	Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals	Lupin Pharmaceuticals	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP, 150 mg doses recalledRifampin	Amerisource Health Services	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Jun 2023Drug	CLASS II	Rifampin Capsules USP, 150 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide