diphenoxylate hydrochloride and atropine sulfate tablets — Class I drug recall D-0150-2018
Terminated recall by Pfizer Inc., reported 2018-01-10, distributed nationwide. SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
| Recall number | D-0150-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2017-10-20 |
| Classified | 2018-01-04 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2020-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 183,437 bottles |
| Reason classes | potency |
| NDC | 59762-1061, 59762-1061-01, 59762-1061-02 |
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 for recall
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0150-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.