Exact FDA event identifier

Event 87602

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: March 26, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lupin Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.

D-0332-2021

Recall number: D-0332-2021
Initiated: March 26, 2021
Classification: Class II
Status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug

Code information

Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021

Distribution pattern

Nationwide in the USA and Puerto Rico