Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97855

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

Open FDA event record

Event summary

Timeline bucket
October 24, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cipla USA, 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

2 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 2

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

D-0217-2026
Recall number
D-0217-2026
Initiated
October 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla USA, Inc.
Quantity
1180 boxes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications: Out of specification for hardness test

Code information

lot# NB240315, exp 12/31/2025

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

D-0218-2026
Recall number
D-0218-2026
Initiated
October 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cipla USA, Inc.
Quantity
N/A

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications: Out of specification for hardness test

Code information

Lot# NB240314, exp 12/31/2025

Distribution pattern

Nationwide in the USA