RecallRadar

FDA Drug recall D-0573-2016

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120…

On 2016-01-27 the FDA classified a Class II recall of Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120… by Freedom Pharmaceuticals, citing presence of Foreign Substance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0573-2016
ClassificationClass II
Statusterminated
Initiated2015-11-09
Published2016-01-27
Last updated2026-09-13 11:51 UTC
CompanyFreedom Pharmaceuticals
DistributionUS

Product

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.

Reason

Presence of Foreign Substance

Identifiers

code_infoLot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2016%22

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