CLASS II Drug recall · Reported 12 Sep 2018 · FDA Enforcement Report
Megestrol Acetate Oral Suspension, USP 400 mg/mL UD cups in boxes recalled
Mckesson is recalling Megestrol Acetate Oral Suspension, USP 400 mg/mL UD cups in boxes, distributed nationwide in the US. The recall was initiated on 14 Aug 2018 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-1172-2018
- FDA event ID
- 80830
- Recalling firm
- Mckesson, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2018
- FDA classified
- 5 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 14 Aug 2018 | Recall initiated by company | |
| 5 Sep 2018 | Classified by FDA | +22 days |
| 12 Sep 2018 | 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
Supterpotent Drug
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 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
Nationwide within the United States
Questions about this recall
Why was it recalled?
Supterpotent Drug
Which lots are affected?
Lot #: 0116158 Exp. 4/30/19; 0113903, 0113902, 0113901, Exp. 8/31/18
Where was it sold?
Nationwide within the United States
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine | McKesson | Temperature Abuse | Nationwide |
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| Drug | CLASS II | Cabtreo (clindamycin phosphate, adapalene recalled by MckessonCabtreo | Mckesson | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
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 III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |