CLASS II Drug recall · Reported 30 Jan 2013 · FDA Enforcement Report
Propylthiouracil Tablets, USP, 50 mg recalled
West-ward Pharmaceutical is recalling Propylthiouracil Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 7 Dec 2012 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-131-2013
- FDA event ID
- 63871
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2012
- FDA classified
- 18 Jan 2013
- Reported
- 30 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Thyroid Medication
Timeline
| 7 Dec 2012 | Recall initiated by company | |
| 18 Jan 2013 | Classified by FDA | +42 days |
| 30 Jan 2013 | Published in enforcement report | +12 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: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Which lots are affected?
Lot #: 68478A, 69059A, 69059B, Exp 01/16
Where was it sold?
Nationwide and Puerto Rico
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.
Other products in this recall event
1 other product · FDA event 63871This product is part of a recall event; the main page for the event is Lisinopril Tablets, USP 40 mg recalled by West-ward Pharmaceutical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lisinopril Tablets, USP 40 mg recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Particulate Matter | Nationwide |
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