CLASS II Drug recall · Reported 18 Jun 2014 · FDA Enforcement Report
Pantoprazole Sodium, Delayed-release tablets, USP dose packages recalled
Legacy Pharmaceutical Packaging is recalling Pantoprazole Sodium, Delayed-release tablets, USP dose packages, distributed in Indiana. The recall was initiated on 9 Apr 2014 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-1363-2014
- FDA event ID
- 67978
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2014
- FDA classified
- 10 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 9 Apr 2014 | Recall initiated by company | |
| 10 Jun 2014 | Classified by FDA | +62 days |
| 18 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam 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
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
Where it was distributed
IN
Questions about this recall
Is Pantoprazole Sodium, Delayed-release tablets, USP dose packages recalled?
Yes. Legacy Pharmaceutical Packaging recalled Pantoprazole Sodium, Delayed-release tablets, USP dose packages on 9 Apr 2014. The recall is Class II and its status is Terminated. Recall number D-1363-2014.
Why was it recalled?
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Which lots are affected?
No lot or expiration date is displayed on this carton.
Where was it sold?
IN
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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