Diphenoxylate Atropine Tablets (Pfizer) – Potency Variation (2017)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Pfizer Inc. is recalling diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle due to SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026