Severity
Low
FDA Drug recall · Reported February 14, 2018
Subpotent Drug: Out of specification for assay (stability testing)
Mckesson Packaging Services recalled Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), … - a low-severity action.
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), … was recalled by Mckesson Packaging Services in February 14, 2018. Reason: Subpotent Drug: Out of specification for assay (stability testing). Check the official notice for the remedy. Verify recall #D-0338-2018 with the FDA Drug before acting.
The recall
Mckesson Packaging Services issued this low-severity FDA Drug recall-Subpotent Drug: Out of specification for assay (stability testing).
Sourced from official FDA Drug enforcement records. Verify recall #D-0338-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0338-2018) was formally reported on February 14, 2018, with the manufacturer initiating the action on January 29, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Mckesson Packaging Services is listed as the recalling firm, operating out of Concord, NC. Federal records list the affected scope as 24120 cups.
The documented reason for this recall is: Subpotent Drug: Out of specification for assay (stability testing) Distribution data in the federal record shows the product reached: U.S.A. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
24120 cups
Related Recalls
6
5 from same agency
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
Subpotent Drug: Out of specification for assay (stability testing)
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0338-2018 |
| Date reported | February 14, 2018 |
| Date initiated | January 29, 2018 |
| Recalling firm | Mckesson Packaging Services |
| Firm location | Concord, NC |
| Affected scope | 24120 cups |
| Distribution | U.S.A. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.