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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78332

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 20, 2017
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Pfizer Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0150-2018
Recall number
D-0150-2018
Initiated
October 20, 2017
Classification
Class I
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
183437 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
SUPERPOTENT

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30

D-0151-2018
Recall number
D-0151-2018
Initiated
October 20, 2017
Classification
Class II
Status
Terminated
Recalling firm
Pfizer Inc.
Quantity
1972 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
SUPERPOTENT

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot: S84026

Distribution pattern

Nationwide in the USA