CLASS III Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled
Mckesson Packaging Services is recalling Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes, distributed nationwide in the US. The recall was initiated on 29 Jan 2018 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-0338-2018
- FDA event ID
- 79060
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jan 2018
- FDA classified
- 8 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Jan 2018 | Recall initiated by company | |
| 8 Feb 2018 | Classified by FDA | +10 days |
| 14 Feb 2018 | 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
Subpotent Drug: Out of specification for assay (stability 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
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled?
Yes. Mckesson Packaging Services recalled Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes on 29 Jan 2018. The recall is Class III and its status is Terminated. Recall number D-0338-2018.
Why was it recalled?
Subpotent Drug: Out of specification for assay (stability testing)
Which lots are affected?
Lot #: 0114588, Exp 10/18
Where was it sold?
U.S.A. 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 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.
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 | Propafenone Hydrochloride tablets, 150 mg recalled | Mckesson Packaging Services | Potency & Assay | 5 states |
Other Megestrol recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Megestrol Acetate Oral Suspension, USP 40 mg/mL recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 625 mg recalled | Breckenridge Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Megestrol Acetate Oral Suspension, USP 400 mg/mL UD cups in boxes recalled | Mckesson | Packaging Defects | Nationwide |