CLASS II ONGOING Drug recall · Reported 28 Dec 2022 · 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 16 Dec 2022 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-0087-2023
- FDA event ID
- 91319
- Recalling firm
- Aurolife Pharma, Dayton, NJ
- Brand
- Glycopyrrolate
- Manufacturer
- Aurolife Pharma LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2022
- FDA classified
- 22 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
Timeline
| 16 Dec 2022 | Recall initiated by company | |
| 22 Dec 2022 | Classified by FDA | +6 days |
| 28 Dec 2022 | 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
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 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Is Glycopyrrolate Tablets, USP, 1 mg recalled?
Yes. Aurolife Pharma recalled Glycopyrrolate Tablets, USP, 1 mg on 16 Dec 2022. The recall is Class II and its status is Ongoing. Recall number D-0087-2023.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 Aurolife Pharma
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | 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 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 |