Glycopyrrolate Tablets — Class II drug recall D-1071-2020
Terminated recall by Par Pharmaceutical Inc., reported 2020-04-08. Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
| Recall number | D-1071-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2020-03-30 |
| Classified | 2020-03-30 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-11-02 |
| Quantity | 29,352 bottles |
| Reason classes | specification failure |
| NDC | 49884-0065-01 |
| Lot numbers | 32809101 |
| Expiration dates | 2021-03 |
Product
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
Reason for recall
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
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-1071-2020. 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.