Procaps S.A. De C.V.

FDA Regulatory Profile

Procaps S.A. De C.V. has 1 FDA recall, 0 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Procaps S.A. De C.V." and its spelling variant "Procaps S.A. De C.V". Records filed under related names are not included; see Related names.

Latest recall
F-0978-2023 · Class II · May 19, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent recalls

1 recall record on May 19, 2023.

NumberClassProductDate
F-0978-2023Class IIBacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028…May 19, 2023

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.