The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-005·Announced 2013-11-13

Mylan Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 5 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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant manufacturing deviations like CGMP violations.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate Tablets, USP, 5 mg, in 90-count and 500-count bottles. The recall involves 167,866 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). The affected lots include 3036490, 3036491, 3036492, 3039874 for 90-count bottles, and 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, and 3044683 for 500-count bottles.

Consumers and healthcare providers should check their inventory for these specific NDC numbers and lot codes. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
167,866

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 (12)

  • Lot s: a) 3036490
  • 3036491
  • 3036492
  • 3039874
  • b) 3036493
  • 3036494
  • 3039872
  • 3039873
  • 3041476
  • 3041477
  • 3044555
  • 3044683

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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