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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91146

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

Open FDA event record

Event summary

Timeline bucket
July 25, 2022
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

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 for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60

D-0068-2023
Recall number
D-0068-2023
Initiated
July 25, 2022
Classification
Class II
Status
Terminated
Quantity
14, 064 (30 sachets in a carton)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration

Code information

Lot #: MHC1317A, Exp 07/2023

Distribution pattern

Nationwide in the USA.