The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-012·Announced 2013-11-13

Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate Tablets, USP 10 mg, in 90-count and 500-count bottles. The recall involves 101,450 bottles distributed nationwide and in Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices.

Consumers should check their medication for the specific NDC numbers (0378-5210-77 or 0378-5210-05) and lot numbers listed in the recall notice. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
101,450

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 (20)

  • Lot #: a) 3038984
  • 3038985
  • 3038986
  • 3041484
  • 3041485
  • b) 3036828
  • 3036829
  • 3036830
  • 3036831
  • 3036832
  • 3038987
  • 3038988
  • 3038989
  • 3038990
  • 3041480
  • 3041481
  • 3041482
  • 3041483
  • 3044522
  • 3044525

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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