Track every drug recall by class. Class I, II, III recalls and market withdrawals resolved to the plant and product, refreshed weekly.
The catalog indexes 27,457 recall events and 30,761 market withdrawals. The Class I cohort (the highest-severity class, with a reasonable probability of serious adverse health consequences or death) carries 1,738 events; Class II 16,124; Class III 9,595. Recent Class I recalls below are drawn from the live `compliance_events` view. Manufacturer attribution is in the recall summary text; PharmaDB resolves to the plant entity where the cited firm name is unambiguous.
Upload products, NDC codes, or supplier plants. PharmaDB resolves to the recall-event taxonomy.
Every new recall in the FDA enforcement report stream is matched against the list weekly. Class I, II, III, and market withdrawals all surface.
Citation-anchored brief per event with the cited reason, the plant attribution, and the related enforcement chip (warning letter, 483 cycle).
Class I, II, III plus market withdrawal. The severity tier shapes the response: Class I is regulatory-action immediate, Class III may be procedural.
Where the recall summary names a manufacturer unambiguously, PharmaDB resolves to the plant entity. The brief carries both the cited firm and the resolved plant.
Plants and products with two or more recalls in trailing 24 months are flagged. The pattern is more predictive of broader CGMP risk than any single event.
FDA enforcement reports publish weekly. PharmaDB tracks the publication date and the recall-initiation date, so a buyer can audit lag in both directions.
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pharmagraph_query Twelve plants with one or more Class I recall in the catalog · recall reason summarised.
The recall monitor is the post-market quality signal. PharmaDB joins recall events to the plant catalog and resolves attribution where possible. The view is compliance_events filtered to event_type IN (recall_class_i, recall_class_ii, recall_class_iii, market_withdrawal). Refresh cadence is weekly.
Class I is a recall where there is a reasonable probability that the product will cause serious adverse health consequences or death. Class II involves temporary or medically reversible harm. Class III involves no expected adverse health consequences but a violation of FDA regulations. Market withdrawal is a non-recall removal for minor reasons.
Recall summaries name a manufacturer and often a distributor. PharmaDB resolves the named manufacturer to its plant entity by canonical name and address match. Where attribution is ambiguous, the catalog row preserves the cited firm without plant resolution.
Microbial contamination (especially in sterile products), product mix-up, and undeclared active-ingredient adulteration are the dominant causes. Plants with repeated aseptic-section 483 observations are statistically more likely to face a Class I event.
The FDA enforcement report publishes weekly. PharmaDB pulls each refresh and surfaces new events within days. The catalog row carries the recall-initiation date and the FDA publication date.
Yes. MHRA NatPSA notifications, EMA Class 1 recalls, Health Canada recalls, and TGA recalls are all tracked. Cross-regulator recall views surface in a combined feed at the buyer's choice.
Yes. Plants with two or more Class I recalls in trailing 24 months get a repeat-recall chip. The pattern is more predictive of broader CGMP risk than any single event and warrants additional qualification scrutiny.
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