Severity
Moderate
FDA Drug recall · Reported August 27, 2014
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Wockhardt Usa Inc. recalled Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle … - a moderate-severity action.
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle … was recalled by Wockhardt Usa Inc. in August 27, 2014. Reason: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four h…. Check the official notice for the remedy. Verify recall #D-1541-2014 with the FDA Drug before acting.
The recall
Wockhardt Usa Inc. issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four h….
Sourced from official FDA Drug enforcement records. Verify recall #D-1541-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1541-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on July 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Wockhardt Usa Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 11,661 HDPE bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. Distribution data in the federal record shows the product reached: 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 - 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 - 3,731 children & baby products 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
11,661 HDPE bottles
Related Recalls
6
0 from same agency
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1541-2014 |
| Date reported | August 27, 2014 |
| Date initiated | July 24, 2014 |
| Recalling firm | Wockhardt Usa Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 11,661 HDPE bottles |
| Distribution | 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 August 27, 2014. 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.