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Class II · ModerateRecall completed

Amlodipine Besylate Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: a) 3038339, Exp 02/14; 3043618, Exp 06/14; b) 3041862, Exp 05/14; 3044258, Exp 06/14; c) 2120031, Exp 01/14; 2120067, Exp 06/14; d) 3035787, 3035834, 3035835, Exp 10/13; 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, Exp 01/14; 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, Exp 02/14; 3040567, 3040977, Exp 04/14; 3041253, 3041800, 3041801, Exp 05/14; 3042446, 3042624, 3043015, Exp 06/14; 3043401, 3043466, Exp 08/14; 3044590, Exp 09/14; 3044591, Exp 10/14; 3045063, 3045064, Exp 11/14
Where it was soldNationwide, Puerto Rico and Guam
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103
Distributed by / forUDL Laboratories, Inc., Rockford, IL 61103
NDC51079-451-20
Show the full FDA record
Full product labelAmlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DistributionNationwide, Puerto Rico and Guam
Quantitya) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons
Recall initiated2013-09-17
Report date2016-08-31
Recall completed2018-04-24
Recall numberD-1467-2016
ClassificationClass II
FDA statusTerminated
Origin on fileRockford IL United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.