RecallRadar

FDA Drug recall D-0275-2022

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr.…

On 2021-12-15 the FDA classified a Class III recall of Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr.… by Dr Reddy S Laboratories, citing failed dissolution specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0275-2022
ClassificationClass III
Statusterminated
Initiated2021-11-12
Published2021-12-15
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionUS

Product

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.

Reason

Failed dissolution specifications

Identifiers

ndc43598-823-14
ndc43598-823-31
ndc43598-823-35
code_infoLot #: AC2103329A

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-0275-2022%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.