CLASS II Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Belladonna Alkaloids with Phenobarbital Tablets recalled
West-Ward Pharmaceutical is recalling Belladonna Alkaloids with Phenobarbital Tablets (, distributed nationwide in the US. The recall was initiated on 30 Jul 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-883-2013
- FDA event ID
- 65844
- Recalling firm
- West-Ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2013
- FDA classified
- 12 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 30 Jul 2013 | Recall initiated by company | |
| 12 Aug 2013 | Classified by FDA | +13 days |
| 21 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Which lots are affected?
1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Belladonna Alkaloids recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Belladonna Alkaloids/PB (Belladonna Alkaloids recalled | Physicians Total Care | Packaging Defects | GA |