CLASS II Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
West-ward Belladonna Alkaloids with Phenobarbital Tablets recalled
West-Ward Pharmaceutical is recalling West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) bottle (, distributed nationwide in the US. The recall was initiated on 16 May 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-825-2013
- FDA event ID
- 65445
- Recalling firm
- West-Ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2013
- FDA classified
- 25 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 16 May 2013 | Recall initiated by company | |
| 25 Jul 2013 | Classified by FDA | +70 days |
| 31 Jul 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Product as listed by the FDA
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Where it was distributed
Nationwide
Questions about this recall
Is West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) bottle ( recalled?
Yes. West-Ward Pharmaceutical recalled West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) bottle ( on 16 May 2013. The recall is Class II and its status is Terminated. Recall number D-825-2013.
Why was it recalled?
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Which lots are affected?
Lot# 67331A, Exp 10/14
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from West-Ward Pharmaceutical
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) 05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | Nationwide |