Amlodipine Besylate Tablets (Walmart) – Label Strength Error (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Legacy Pharmaceutical Packaging LLC
Lot Codes / Batch Numbers
Lot # 130251, 130252, 130253 Exp date: 11/14
Products Sold
Lot # 130251, 130252, 130253 Exp date: 11/14
Legacy Pharmaceutical Packaging LLC is recalling Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharma due to 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. . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026