Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97629

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

Open FDA event record

Event summary

Timeline bucket
September 15, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Graviti Pharmaceuticals Private Limited

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

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

D-0037-2026
Recall number
D-0037-2026
Initiated
September 15, 2025
Classification
Class II
Status
Ongoing
Quantity
46,512/30 count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications

Code information

Batch # BPB124341A, Exp date: 10/2026

Distribution pattern

Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.