Health Canada Drugs & Medical Devices Brief

Headline

Health Canada issues Type II recall of JAMP Temozolomide 140 mg capsules for out-of-specification active ingredient

Executive Summary

Health Canada published recall RA-82571 on August 31, 2026, covering one lot of JAMP Temozolomide 140 mg capsules distributed by JAMP Pharma Corporation. The affected lot, RLTS0225A, fails assay specification for temozolomide, the active chemotherapy ingredient.

Bottom Line

The recall covers one lot of a chemotherapy capsule whose active ingredient fails assay specification, placing the quality defect directly in the therapeutic window of an oncology product. Pharmacies and dispensing institutions are responsible for quarantining lot RLTS0225A and notifying affected patients. Patients are directed to consult a healthcare provider before discontinuing the product, a requirement that places a communication obligation on the dispensing party, not only on the patient.

Key Regulatory Signals

• Single Lot Affected, Retail Depth: The recall reaches the retail level, meaning product may be in patient hands or pharmacy dispensing stock. Pharmacies and dispensing institutions holding lot RLTS0225A must verify inventory against the identified lot number.
• Out-of-Specification Active Ingredient: The assay failure means the temozolomide content in lot RLTS0225A does not meet the approved specification. For patients on a chemotherapy regimen, a sub- or super-potent dose carries direct clinical consequence, making this a patient-safety matter beyond a routine quality deviation.
• Type II Classification: Health Canada's Type II recall classification indicates that use of the affected product may cause temporary adverse health consequences, but the probability of serious harm is considered remote. This classification governs the urgency and scope of the recall response required of distributors and retailers.
• Patient Guidance Requires Healthcare Provider Involvement: Health Canada's direction explicitly instructs patients not to discontinue use without first consulting a healthcare provider. Abrupt cessation of temozolomide in an active treatment course carries its own clinical risk, and that instruction is load-bearing for any pharmacy or clinic communicating the recall to patients.

Regulatory Delta

- No direct precedent for a temozolomide assay recall in Canada was identified. This is an isolated product-quality action, not part of a pattern of enforcement against JAMP Pharma Corporation.

- The Type II classification, rather than Type I, indicates Health Canada assessed the probability of serious harm as remote. This distinguishes the recall from actions requiring immediate product removal before any clinical consultation.

- The recall is confined to a single lot and a single strength, limiting scope to dispensers and patients who received lot RLTS0225A specifically.

Materiality Classification

MEDIUM — A Type II Health Canada drug recall for an out-of-specification chemotherapy active ingredient requires inventory verification and patient notification by all pharmacies and dispensing institutions holding the affected lot, extending the compliance obligation beyond the named manufacturer.

Intelligence Outlook

Monitor Health Canada recalls and safety alerts for updates to this recall, including any reclassification, expansion to additional lots, or issuance of a Type I designation.