Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88873

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

Open FDA event record

Event summary

Timeline bucket
October 25, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SUN PHARMACEUTICAL INDUSTRIES 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

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01

D-0230-2022
Recall number
D-0230-2022
Initiated
October 25, 2021
Classification
Class II
Status
Terminated
Quantity
73,957 30-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Code information

Lot # DNC1127A, exp. date 05/2023

Distribution pattern

Distributed to one distributor who may have further distribute the product nationwide.

drug · product 2 of 2

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01

D-0231-2022
Recall number
D-0231-2022
Initiated
October 25, 2021
Classification
Class II
Status
Terminated
Quantity
36,786 30-count bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Code information

Lot # DNC0814A, DNC0815A, Exp. Date 04/2023

Distribution pattern

Distributed to one distributor who may have further distribute the product nationwide.

Field note

Send feedback

We'll only use this to respond to your feedback.