CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report

Pyridostigmine Bromide Tablets USP, 60 mg recalled by Corepharma

Corepharma is recalling Pyridostigmine Bromide Tablets USP, 60 mg, distributed nationwide in the US. The recall was initiated on 13 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s and Exp dates: 106019 exp December-13 106020 exp December -13 106336 exp January-14 106337 exp January-14 106338 exp January-14 106097 exp February-14 106098 exp February-14 106099 exp February-14 106100 exp April-14 106545 exp April-14 106664 exp April-14 107208 exp July-14 107363 exp October-14 107574 exp October-14 107629 exp October-14 108167 exp February-15 108168 exp February-15 108169 exp February-15 108322 exp May-15

Quantity recalled174,888 Bottles

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-1079-2014
FDA event ID: 67291
Recalling firm: Corepharma, Middlesex, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Dec 2013
FDA classified: 5 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

13 Dec 2013	Recall initiated by company
5 Feb 2014	Classified by FDA	+54 days
12 Feb 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

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 USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Which lots are affected?

Lot #s and Exp dates: 106019 exp December-13 106020 exp December -13 106336 exp January-14 106337 exp January-14 106338 exp January-14 106097 exp February-14 106098 exp February-14 106099 exp February-14 106100 exp April-14 106545 exp April-14 106664 exp April-14 107208 exp July-14 107363 exp October-14 107574 exp October-14 107629 exp October-14 108167 exp February-15 108168 exp February-15 108169 exp February-15 108322 exp May-15

Where was it sold?

Nationwide 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 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.

Other Pyridostigmine recalls

All 3

Reported	Class	Recall	Company	Reason	Where
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide
2 Oct 2013Drug	CLASS II	Pyridostigmine Bromide Tablets 60 mg recalled by Core Pharma	Core Pharma	Potency & Assay	Nationwide