CLASS II Drug recall · Reported 2 Oct 2013 · FDA Enforcement Report
Pyridostigmine Bromide Tablets 60 mg recalled by Core Pharma
Core Pharma is recalling Pyridostigmine Bromide Tablets 60 mg, USP, distributed nationwide in the US. The recall was initiated on 2 Jul 2013 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-1062-2013
- FDA event ID
- 65889
- Recalling firm
- Core Pharma, Middlesex, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2013
- FDA classified
- 20 Sep 2013
- Reported
- 2 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Jul 2013 | Recall initiated by company | |
| 20 Sep 2013 | Classified by FDA | +80 days |
| 2 Oct 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
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
Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Where it was distributed
Nationwide
Questions about this recall
Is Pyridostigmine Bromide Tablets 60 mg, USP recalled?
Yes. Core Pharma recalled Pyridostigmine Bromide Tablets 60 mg, USP on 2 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-1062-2013.
Why was it recalled?
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Which lots are affected?
109497; Exp. 12/15
Where was it sold?
Nationwide
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.
Other Pyridostigmine bromide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Tablets USP, 60 mg recalled by Corepharma | Corepharma | Potency & Assay | Nationwide |