Exact FDA event identifier

Event 98671

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, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Hetero Labs Limited (Unit V)

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

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

D-0484-2026

Recall number: D-0484-2026
Initiated: March 26, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Hetero Labs Limited (Unit V)
Quantity: 4,740 1,000-count bottles.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Code information

Batch # FD253967, Exp Date: 06/26/2027

Distribution pattern

Nationwide in the USA.