US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2013 (13 years ago)

Walmart Amlodipine Besylate Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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.

Recalling firm
Legacy Pharmaceutical Packaging LLC
NDC code
68645-445-70
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-319-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Amlodipine recalls

See all
Class II · Moderate risk Ongoing

Amlodipine and Olmesartan Medoxomil Tablets

Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Ascend Laboratories, LLC D-0712-2026
Class II · Moderate risk Ongoing

Amlodipine and Olmesartan Medoxomil Tablets

Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Ascend Laboratories, LLC NDC 67877-501-30 D-0556-2026
Class II · Moderate risk Terminated

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Lupin Pharmaceuticals Inc. NDC 68180-755-01 D-0542-2025
Class III · Low risk Terminated

Amlodipine Besylate Tablets

Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-721-03 D-0899-2023