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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71865

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ranbaxy 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

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

D-1288-2015
Recall number
D-1288-2015
Initiated
June 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Ranbaxy Inc.
Quantity
9,229 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

Code information

Lot #:14H04AA, Expiry: 02/28/2017.

Distribution pattern

Nationwide