CLASS III Drug recall · Reported 20 Feb 2013 · FDA Enforcement Report
Glycopyrrolate Tablets, USP, 1 mg recalled by West-ward Pharmaceutical
West-ward Pharmaceutical is recalling Glycopyrrolate Tablets, USP, 1 mg, distributed in Ohio. The recall was initiated on 7 Jan 2013 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-164-2013
- FDA event ID
- 64108
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jan 2013
- FDA classified
- 12 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Jan 2013 | Recall initiated by company | |
| 12 Feb 2013 | Classified by FDA | +36 days |
| 20 Feb 2013 | 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
Subpotent Drug
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, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
Where it was distributed
OH
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 69001A
Where was it sold?
OH
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.
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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 |