CLASS I Drug recall · Reported 10 Jan 2018 · FDA Enforcement Report
diphenoxylate hydrochloride and atropine sulfate tablets recalled
Pfizer is recalling diphenoxylate hydrochloride and atropine sulfate tablets, USP, 5 mg/0.025 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 20 Oct 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0150-2018
- FDA event ID
- 78332
- Recalling firm
- Pfizer, New York, NY
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Oct 2017
- FDA classified
- 4 Jan 2018
- Reported
- 10 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Oct 2017 | Recall initiated by company | |
| 4 Jan 2018 | Classified by FDA | +76 days |
| 10 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is diphenoxylate hydrochloride and atropine sulfate tablets, USP, 5 mg/0.025 mg, a) bottle ( recalled?
Yes. Pfizer recalled diphenoxylate hydrochloride and atropine sulfate tablets, USP, 5 mg/0.025 mg, a) bottle ( on 20 Oct 2017. The recall is Class I and its status is Terminated. Recall number D-0150-2018.
Why was it recalled?
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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