BIOCON PHARMA INC

FDA Regulatory Profile

BIOCON PHARMA INC has 2 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "BIOCON PHARMA INC" and its spelling variants "Biocon Pharma", "Biocon Pharma Limited".

Latest recall
D-0306-2025 · Class II · Mar 17, 2025
Latest inspection
Jun 2, 2023 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

BIOCON PHARMA INC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

BIOCON PHARMA INC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500010
202400000
202310010
202200000
202100000
202000000
201900000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

2 recall records from Jan 31, 2023 to Mar 17, 2025.

NumberClassProductDate
D-0306-2025Class IIAtorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma…Mar 17, 2025
D-0268-2023Class IIPosaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon…Jan 31, 2023

Recent FDA inspections

1 inspection on Jun 2, 2023.

DateSiteProductClassificationFEI
Jun 2, 2023Bengaluru, IndiaDrugsNo Action Indicated (NAI)3013637926
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013637926Bengaluru, India1Jun 2, 2023

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