CLASS III Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report

Temozolomide capsules, 20 mg recalled by Amerigen Pharmaceuticals

Amerigen Pharmaceuticals is recalling Temozolomide capsules, 20 mg, distributed nationwide in the US. The recall was initiated on 5 Oct 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19

Quantity recalled5,232 bottles: a) 4,146 bottles; b) 1,086 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-0249-2019
FDA event ID: 81189
Recalling firm: Amerigen Pharmaceuticals, Lyndhurst, NJ
Classification: Class III
Status: Terminated
Recall initiated: 5 Oct 2018
FDA classified: 15 Nov 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

5 Oct 2018	Recall initiated by company
24 Oct 2018	Published in enforcement report	+19 days
15 Nov 2018	Classified by FDA	+22 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 dissolution results obtained during stability testing.

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

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

Where it was distributed

Product was distributed U.S. nationwide.

Nationwide

Questions about this recall

Is Temozolomide capsules, 20 mg recalled?

Yes. Amerigen Pharmaceuticals recalled Temozolomide capsules, 20 mg on 5 Oct 2018. The recall is Class III and its status is Terminated. Recall number D-0249-2019.

Why was it recalled?

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

Which lots are affected?

Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19

Where was it sold?

Product was distributed 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Amerigen Pharmaceuticals

All 4

Reported	Class	Recall	Company	Reason	Where
27 Feb 2019Drug	CLASS III	Temozolomide Capsules, 5 mg recalled by Amerigen Pharmaceuticals	Amerigen Pharmaceuticals	Potency & Assay	Nationwide
2 Jan 2019Drug	CLASS III	Temozolomide Capsules, 20 mg recalled by Amerigen Pharmaceuticals	Amerigen Pharmaceuticals	Potency & Assay	NJ
2 Jan 2019Drug	CLASS III	Temozolomide Capsules, 180 mg recalled by Amerigen Pharmaceuticals	Amerigen Pharmaceuticals	Potency & Assay	NJ

Other Temozolomide recalls

All 15

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Drug	CLASS II	Product label: Temozolomide Capsules, 5mg recalledTemozolomide	Rising Pharma Holding	Potency & Assay	Nationwide
31 Jul 2019Drug	CLASS II	Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide	Deva Holding AS - Cerkezkoy Subesi	Manufacturing (CGMP) Deviations	Nationwide
31 Jul 2019Drug	CLASS II	Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide	Deva Holding AS - Cerkezkoy Subesi	Manufacturing (CGMP) Deviations	Nationwide
31 Jul 2019Drug	CLASS II	Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide	Deva Holding AS - Cerkezkoy Subesi	Manufacturing (CGMP) Deviations	Nationwide
31 Jul 2019Drug	CLASS II	Temozolomide Capsules, 20 mg recalled by Deva Holding AS - CerkezkoyTemozolomide	Deva Holding AS - Cerkezkoy Subesi	Manufacturing (CGMP) Deviations	Nationwide