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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85960

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2020
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

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

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

D-1406-2020
Recall number
D-1406-2020
Initiated
July 02, 2020
Classification
Class II
Status
Terminated
Quantity
35,928 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: Out-of-specification (OOS) result observed in an assay test of retention samples.

Code information

Lot # F802189, Exp 10/2020, F900240, Exp 1/2021

Distribution pattern

U.S.A. Nationwide