The Recall Desk
ModerateFDA (Drugs)·D-319-2013·Announced 2013-05-22

Walmart Amlodipine Tablets Recalled for Labeling Error

Legacy Pharmaceutical Packaging is recalling Walmart Amlodipine Besylate Tablets 10 mg due to a label error listing 5 mg in the USP description.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the declared strength, which fits the rubric for moderate severity.

Plain-English summary

Legacy Pharmaceutical Packaging LLC is recalling 484,236 cartons of Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets. The product is manufactured by InvaGen Pharmaceuticals, Inc., manufactured for Camber Pharmaceuticals, Inc., and distributed by Wal-Mart Stores, Inc. The recall covers lots 130251, 130252, and 130253 with an expiration date of 11/14.

The recall was initiated due to a labeling error. The product label contains a misprint in the USP description where 5 mg is listed, although the actual tablet strength is 10 mg. The agency has classified this as a Class II recall.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

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 Pharmac
Affected units
484,236

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # 130251
  • 130252
  • 130253 Exp date: 11/14

Distribution

Distributed nationwide across the United States.