Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported December 19, 2018
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Mylan Laboratories Limited, (Nashik Fdf) recalled Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for:… - a moderate-severity action.
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for:… was recalled by Mylan Laboratories Limited, (Nashik Fdf) in December 19, 2018. Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA…. Check the official notice for the remedy. Verify recall #D-0324-2019 with the FDA Drug before acting.
The recall
Mylan Laboratories Limited, (Nashik Fdf) issued this moderate-severity FDA Drug recall-GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA….
- Moderate
- severity level
- Class II
- classification
- December 19, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0324-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0324-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on December 4, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Mylan Laboratories Limited, (Nashik Fdf) is listed as the recalling firm, operating out of Sinnar, Nashik District, N/A. Federal records list the affected scope as 160,300 HDPE bottles.
The documented reason for this recall is: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Distribution data in the federal record shows the product reached: Product was distributed throughout the United States to several major distributors, including Puerto Rico.. 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.
Drugs & Medications recalls over time
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.
Affected scope
160,300 HDPE bottles
Related Recalls
6
5 from same agency
Product description
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0324-2019 |
| Date reported | December 19, 2018 |
| Date initiated | December 4, 2018 |
| Recalling firm | Mylan Laboratories Limited, (Nashik Fdf) |
| Firm location | Sinnar, Nashik District, N/A |
| Affected scope | 160,300 HDPE bottles |
| Distribution | Product was distributed throughout the United States to several major distributors, including Puerto Rico. |
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-0324-2019) 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.
Frequently Asked Questions
What product was recalled? ▼
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.. Recalled by Mylan Laboratories Limited, (Nashik Fdf). Units affected: 160,300 HDPE bottles.
Why was this product recalled? ▼
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 19, 2018. Severity: Moderate. Recall number: D-0324-2019.
Where was the recalled product distributed? ▼
Distribution: Product was distributed throughout the United States to several major distributors, including Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0324-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 December 19, 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.