CLASS III Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report

Aspirin DR Enteric Coated Tablets, USP 325 mg, UD recalled

Mckesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets, USP 325 mg, UD, distributed nationwide in the US. The recall was initiated on 19 Jun 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 0093943
Quantity recalled1,511,250 tablets

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-1483-2014
FDA event ID
68652
Recalling firm
Mckesson Packaging Services, Concord, NC
Classification
Class III
Status
Terminated
Recall initiated
19 Jun 2014
FDA classified
28 Jul 2014
Reported
6 Aug 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay
Drug class
Pain Medication

Timeline

19 Jun 2014Recall initiated by company
28 Jul 2014Classified by FDA+39 days
6 Aug 2014Published in enforcement report+9 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; at the 12 month time interval.

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

Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specification; at the 12 month time interval.

Which lots are affected?

Lot 0093943

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 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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