CLASS III Drug recall · Reported 4 May 2016 · FDA Enforcement Report
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose (25 recalled
Mckesson Packaging Services is recalling SKY Aspirin Chewable Tablets, 81 mg, Unit Dose (25 x, distributed nationwide in the US. The recall was initiated on 12 Apr 2016 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-0834-2016
- FDA event ID
- 73874
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Apr 2016
- FDA classified
- 28 Apr 2016
- Reported
- 4 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 12 Apr 2016 | Recall initiated by company | |
| 28 Apr 2016 | Classified by FDA | +16 days |
| 4 May 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Product as listed by the FDA
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Which lots are affected?
Lot 0110701
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.
More recalls from Mckesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |