CLASS II Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Walmart Amlodipine Besylate Tablets, USP 10 mg recalled
Legacy Pharmaceutical Packaging is recalling Walmart Amlodipine Besylate Tablets, USP 10 mg, distributed nationwide in the US. The recall was initiated on 22 Apr 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-319-2013
- FDA event ID
- 64974
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 22 Apr 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +24 days |
| 22 May 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
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
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
Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70.
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Which lots are affected?
Lot # 130251, 130252, 130253 Exp date: 11/14
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 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.
More recalls from Legacy Pharmaceutical Packaging
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|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
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| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |