Severity
Moderate
FDA Drug recall · Reported March 27, 2019
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Legacy Pharmaceutical Packaging LLC recalled Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-M… - a moderate-severity action.
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-M… was recalled by Legacy Pharmaceutical Packaging LLC in March 27, 2019. Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. Check the official notice for the remedy. Verify recall #D-1049-2019 with the FDA Drug before acting.
The recall
Legacy Pharmaceutical Packaging LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Sourced from official FDA Drug enforcement records. Verify recall #D-1049-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1049-2019) was formally reported on March 27, 2019, with the manufacturer initiating the action on March 1, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Legacy Pharmaceutical Packaging LLC is listed as the recalling firm, operating out of Earth City, MO. Federal records list the affected scope as 2,851,284 bottles.
The documented reason for this recall is: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Distribution data in the federal record shows the product reached: Wal-Mart distribution centers in AR, CA, GA, IN and MD. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
2,851,284 bottles
Related Recalls
6
5 from same agency
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-1049-2019 |
| Date reported | March 27, 2019 |
| Date initiated | March 1, 2019 |
| Recalling firm | Legacy Pharmaceutical Packaging LLC |
| Firm location | Earth City, MO |
| Affected scope | 2,851,284 bottles |
| Distribution | Wal-Mart distribution centers in AR, CA, GA, IN and MD |
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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Lupin Pharmaceuticals Inc. · 2026-05-27
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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 March 27, 2019. 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.