FDA Drug recall · Reported May 8, 2019
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Legacy Pharmaceutical Packaging LLC recalled Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The K… - a moderate-severity action.
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The K… was recalled by Legacy Pharmaceutical Packaging LLC in May 8, 2019. Reason: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Activ…. Check the official notice for the remedy. Verify recall #D-1263-2019 with the FDA Drug before acting.
The recall
Legacy Pharmaceutical Packaging LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Activ….
- Moderate
- severity level
- Class II
- classification
- May 8, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1263-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
Reason for recall
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-1263-2019 |
| Date reported | May 8, 2019 |
| Date initiated | April 24, 2019 |
| Recalling firm | Legacy Pharmaceutical Packaging LLC |
| Firm location | Earth City, MO |
| Affected scope | 60,012 bottles |
| Distribution | TN, AZ |
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.
- Check the recall number (D-1263-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026