Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97182

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, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
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

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

D-0542-2025
Recall number
D-0542-2025
Initiated
July 02, 2025
Classification
Class II
Status
Ongoing
Quantity
7668 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Code information

Lot GB01616, expiration 2/28/2027

Distribution pattern

Nationwide in the US