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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84196

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 01, 2019
Product types
Drug
Classifications
Class III
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

3 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 3

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

D-0304-2020
Recall number
D-0304-2020
Initiated
November 01, 2019
Classification
Class III
Status
Terminated
Quantity
28,254 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Code information

Lot #: F802436, F802437, F802438, F802442, Exp 11/20

Distribution pattern

Product was distributed to major distributors/wholesalers throughout the United States.

drug · product 2 of 3

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

D-0305-2020
Recall number
D-0305-2020
Initiated
November 01, 2019
Classification
Class III
Status
Terminated
Quantity
30,516 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Code information

Lot #: F802345, F802346, F802347, Exp 11/20

Distribution pattern

Product was distributed to major distributors/wholesalers throughout the United States.

drug · product 3 of 3

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

D-0306-2020
Recall number
D-0306-2020
Initiated
November 01, 2019
Classification
Class III
Status
Terminated
Quantity
a) 4074 bottles b) 30,300 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Code information

Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20

Distribution pattern

Product was distributed to major distributors/wholesalers throughout the United States.