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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82714

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

Open FDA event record

Event summary

Timeline bucket
April 25, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zydus Pharmaceuticals USA 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

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01

D-1272-2019
Recall number
D-1272-2019
Initiated
April 25, 2019
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Code information

Z804517, Nov 30, 2020

Distribution pattern

Nationwide

drug · product 2 of 2

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

D-1273-2019
Recall number
D-1273-2019
Initiated
April 25, 2019
Classification
Class II
Status
Terminated
Quantity
3900

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling; Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Code information

Z804517, exp Nov 30, 2020

Distribution pattern

Nationwide