The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-66403-001·Announced 2013-11-13

Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 2.5 mg, because they were not manufactured according to Good Manufacturing Practices.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate Tablets, USP, 2.5 mg, in 90-count and 500-count bottles. The recall involves 37,752 bottles distributed nationwide and in Puerto Rico.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices (CGMP Deviations). This classification is designated as Class II by the FDA.

Consumers with these products should contact their healthcare provider or pharmacist for guidance on alternative treatment options. The specific lot numbers affected are 3037907, 3040106, and 3044357.

The recalled product

Product
Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
37,752

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 (4)

  • Lot #: a) 3037907
  • 3040106
  • b) 3037907
  • 3044357

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Mylan Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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