RecallRadar

FDA Drug recall D-0150-2018

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottl…

On 2018-01-10 the FDA classified a Class I recall of diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottl… by Pfizer, citing SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0150-2018
ClassificationClass I
Statusterminated
Initiated2017-10-20
Published2018-01-10
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977

Reason

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

Identifiers

ndc59762-1061-1
ndc59762-1061-2
code_info
Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NO…Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.

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-0150-2018%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.