CLASS II Drug recall · Reported 8 Apr 2020 · FDA Enforcement Report
Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical
Par Pharmaceutical is recalling Glycopyrrolate Tablets, USP 1 mg. The recall was initiated on 30 Mar 2020 and the FDA has classified it as Class II.
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-1071-2020
- FDA event ID
- 85333
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Mar 2020
- FDA classified
- 30 Mar 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 30 Mar 2020 | Recall initiated by company | |
| 30 Mar 2020 | Classified by FDA | +0 days |
| 8 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
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
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
Where it was distributed
Product was distributed within the United States.
Questions about this recall
Is Glycopyrrolate Tablets, USP 1 mg recalled?
Yes. Par Pharmaceutical recalled Glycopyrrolate Tablets, USP 1 mg on 30 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1071-2020.
Why was it recalled?
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Which lots are affected?
Lot # 32809101, Exp 3/2021
Where was it sold?
Product was distributed within the United States.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Par Pharmaceutical
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|---|---|---|---|---|---|
| Drug | CLASS II | BusPIRone Hydrochloride Tablets, USP 5 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Frovatriptan Succinate Tablets, 5mg recalled by Par Pharmaceutical | Par Pharmaceutical | Labeling Errors | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
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Other Glycopyrrolate recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per 2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate | Novadoz Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate | HF Acquisition Co | Packaging Defects | AZ, CA, TX |