RecallRadar

FDA Drug recall D-170-2013

Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg

On 2013-03-06 the FDA classified a Class II recall of Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg by West Ward Pharmaceutical, citing presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-170-2013
ClassificationClass II
Statusterminated
Initiated2013-01-07
Published2013-03-06
Last updated2026-09-13 11:51 UTC
CompanyWest Ward Pharmaceutical
DistributionUS

Product

Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724

Reason

Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Identifiers

code_infoLot #: 69099A, 69099B, Exp 08/15

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-170-2013%22

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