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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88474

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SigmaPharm 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

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

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

D-0766-2021
Recall number
D-0766-2021
Initiated
August 13, 2021
Classification
Class II
Status
Terminated
Quantity
1,993 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Code information

Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024

Distribution pattern

Disttibuted Nationwide in the USA.