Recall events
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Event 90891
Event summary
Timeline bucket June 21, 2022
Product types Drug
Classifications Class III
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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
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
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
D-0004-2023
Recall number D-0004-2023
Initiated June 21, 2022
Classification Class III
Status Terminated
Quantity 5712 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Superpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Code information Lot AC14299, Exp 12/2022
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15979]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 2
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
D-0005-2023
Recall number D-0005-2023
Initiated June 21, 2022
Classification Class III
Status Terminated
Quantity 8640 bottles
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Superpotent
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Code information Lot AC14304, Exp 12/2022.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15005]
FDA event record
· Exact recall-number query on openFDA
