RecallRadar

FDA Drug recall D-1282-2020

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC:…

On 2020-05-27 the FDA classified a Class III recall of Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC:… by West Ward Columbus, citing failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1282-2020
ClassificationClass III
Statusterminated
Initiated2020-05-13
Published2020-05-27
Last updated2026-09-13 11:52 UTC
CompanyWest Ward Columbus
DistributionUS

Product

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.

Reason

Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

Identifiers

code_infoLot #: AA4424A, Exp. 07/31/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1282-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.