CLASS II Drug recall · Reported 24 Aug 2016 · FDA Enforcement Report

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg recalled

Golden State Medical Supply is recalling Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg per, distributed nationwide in the US. The recall was initiated on 3 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017

Quantity recalled40,631 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-1459-2016
FDA event ID: 74847
Recalling firm: Golden State Medical Supply, Camarillo, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Aug 2016
FDA classified: 16 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antidepressants

Timeline

3 Aug 2016	Recall initiated by company
16 Aug 2016	Classified by FDA	+13 days
24 Aug 2016	Published in enforcement report	+8 days

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

Reason for recall

Failed Dissolution Specifications: Out-of-specification results in retained sample.

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

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: Out-of-specification results in retained sample.

Which lots are affected?

Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017

Where was it sold?

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 74847

This product is part of a recall event; the main page for the event is Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) recalled.

Reported	Class	Recall	Company	Reason	Where
24 Aug 2016	CLASS II	Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) recalled	Golden State Medical Supply	Potency & Assay	Nationwide

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 Venlafaxine recalls

All 26

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine	Zydus Pharmaceuticals	Foreign Material	Nationwide
29 Jan 2025Drug	CLASS III	Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine	Appco Pharma	Other	Nationwide
31 Jul 2024Drug	CLASS II	Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg recalledVenlafaxine Hydrochloride	Zydus Pharmaceuticals	Potency & Assay	Nationwide
10 Jul 2024Drug	CLASS II	Venlafaxine Hydrochloride, extended-release capsules recalled	The Harvard Drug Group	Potency & Assay	Nationwide
18 Aug 2021Drug	CLASS II	Venlafaxine Tablets, USP 50 mg* recalled	SUN Pharmaceutical Industries	Other	TN