Severity
Moderate
FDA Drug recall · Reported August 21, 2013
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
West-Ward Pharmaceutical Corp. recalled Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 c… - a moderate-severity action.
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 c… was recalled by West-Ward Pharmaceutical Corp. in August 21, 2013. Reason: Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets. Check the official notice for the remedy. Verify recall #D-883-2013 with the FDA Drug before acting.
The recall
West-Ward Pharmaceutical Corp. issued this moderate-severity FDA Drug recall-Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets.
Sourced from official FDA Drug enforcement records. Verify recall #D-883-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-883-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. West-Ward Pharmaceutical Corp. is listed as the recalling firm, operating out of Eatontown, NJ. Federal records list the affected scope as 1000 count bottles/61,370 and 5000 count bottles/321.
The documented reason for this recall is: Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets 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, 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
1000 count bottles/61,370 and 5000 count bottles/321
Related Recalls
6
5 from same agency
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-883-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 30, 2013 |
| Recalling firm | West-Ward Pharmaceutical Corp. |
| Firm location | Eatontown, NJ |
| Affected scope | 1000 count bottles/61,370 and 5000 count bottles/321 |
| 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 21, 2013. 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.