What does pharmaceutical products liability insurance not cover?

Known prior defects: any defect known before policy inception is excluded. Coverage attaches only to claims arising from manufacture or distribution within the policy period (occurrence form) or from claims first made during the policy period (claims-made form).

Recall first-party costs: products liability covers third-party bodily injury and property damage, not the operator's own cost of pulling product back. Dedicated product recall coverage with first-party limits (typically $1M-$10M for mid-market operators) fills this gap.

Off-label promotion: pharmaceutical operators promoting product for indications outside the FDA-approved label face exclusion. Disciplined marketing review and pharmacovigilance discipline are the underlying control, not an insurance fix.

Withdrawn products: once a product is voluntarily withdrawn or recalled, future claims are typically excluded prospectively. Extended reporting period (tail) coverage on claims-made policies addresses the legacy tail.

Contractual liability not separately endorsed: indemnity obligations assumed by contract are excluded from baseline general liability unless the policy includes an insured contract endorsement or contractual liability extension matching the sponsor MSA / GPO contract language.