CLASS III Drug recall · Reported 28 Jun 2023 · FDA Enforcement Report
Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife Pharma
Aurolife Pharma is recalling Glycopyrrolate Tablets, USP, 1 mg, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class III.
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-0877-2023
- FDA event ID
- 92379
- Recalling firm
- Aurolife Pharma, Dayton, NJ
- Brand
- Glycopyrrolate
- Manufacturer
- Aurolife Pharma LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 May 2023
- FDA classified
- 20 Jun 2023
- Reported
- 28 Jun 2023
- Reason category
- Potency & Assay
Timeline
| 18 May 2023 | Recall initiated by company | |
| 20 Jun 2023 | Classified by FDA | +33 days |
| 28 Jun 2023 | Published in enforcement report | +8 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 Specifications
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 bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 01421038A1, Exp. Date 05/2023
Where was it sold?
Nationwide 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 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 Aurolife Pharma
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg recalled | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, equate recalled | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fexofenadine Hydrochrloride Tablets USP, 180 mg recalled | Aurolife Pharma | Potency & Assay | Nationwide |
Other Glycopyrrolate recalls
All 43| 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 (0.2 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 II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | glycopyrrolate 1 mg/ (0.2 mg/mL), For Anesthesia Use, Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |