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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91442

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

Open FDA event record

Event summary

Timeline bucket
January 05, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ascend Laboratories, LLC

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

3 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 3

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.

D-0169-2023
Recall number
D-0169-2023
Initiated
January 05, 2023
Classification
Class II
Status
Terminated
Recalling firm
Ascend Laboratories, LLC
Quantity
49,632 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specification

Code information

Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 3

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.

D-0170-2023
Recall number
D-0170-2023
Initiated
January 05, 2023
Classification
Class II
Status
Terminated
Recalling firm
Ascend Laboratories, LLC
Quantity
6,336 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specification

Code information

Lot #: 21142633, Exp 03/31/2023

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 3

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.

D-0171-2023
Recall number
D-0171-2023
Initiated
January 05, 2023
Classification
Class II
Status
Terminated
Recalling firm
Ascend Laboratories, LLC
Quantity
2628 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specification

Code information

Lot#: 21141321, 21141322, Exp 01/31/2023.

Distribution pattern

Nationwide and Puerto Rico