CLASS II Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report
ZEE Aspirin 325mg - in single dose packets recalled
Zee Medical Products is recalling ZEE Aspirin 325mg - in single dose packets, distributed nationwide in the US. The recall was initiated on 7 Oct 2014 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-0041-2015
- FDA event ID
- 69538
- Recalling firm
- Zee Medical Products, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2014
- FDA classified
- 22 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 7 Oct 2014 | Recall initiated by company | |
| 22 Oct 2014 | Classified by FDA | +15 days |
| 29 Oct 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
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Product as listed by the FDA
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
Where it was distributed
Nationwide in US
Questions about this recall
Is ZEE Aspirin 325mg - in single dose packets recalled?
Yes. Zee Medical Products recalled ZEE Aspirin 325mg - in single dose packets on 7 Oct 2014. The recall is Class II and its status is Terminated. Recall number D-0041-2015.
Why was it recalled?
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Which lots are affected?
Lot No. AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, AK7062
Where was it sold?
Nationwide in US
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.