CLASS II Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg recalled
Wockhardt Usa is recalling Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, distributed nationwide in the US. The recall was initiated on 27 Nov 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-1042-2014
- FDA event ID
- 67238
- Recalling firm
- Wockhardt Usa, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2013
- FDA classified
- 29 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 27 Nov 2013 | Recall initiated by company | |
| 29 Jan 2014 | Classified by FDA | +63 days |
| 5 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Where it was distributed
Nationwide including Puerto Rico
Questions about this recall
Is Pantaprazole Sodium Delayed Release Tablets , USP 40 mg recalled?
Yes. Wockhardt Usa recalled Pantaprazole Sodium Delayed Release Tablets , USP 40 mg on 27 Nov 2013. The recall is Class II and its status is Terminated. Recall number D-1042-2014.
Why was it recalled?
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Which lots are affected?
Lot: #: DM12286, Expiry: 06/14.
Where was it sold?
Nationwide including 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 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.
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|---|---|---|---|---|---|
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