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MYLAN PHARMACEUTICALS Recalls
81 recalls on record · October 3, 2012 to August 5, 2026 · Drugs, Food & Beverage
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 27, 2014DrugsFDA
Mylan Pharmaceuticals Inc. recalls Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC:
Hazard: Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
February 19, 2014DrugsFDA
Mylan Pharmaceuticals Inc. recalls Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgant
Hazard: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, N
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Mo
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottl
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Mor
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b)
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b)
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.,
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., M
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
November 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (N
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
June 5, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharm
Hazard: Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
May 1, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV
Hazard: Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
February 13, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharm
Hazard: Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
February 6, 2013DrugsFDA
Mylan Pharmaceuticals Inc. recalls Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 2650
Hazard: Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
October 31, 2012DrugsFDA
Mylan Pharmaceuticals Inc. recalls Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15
Hazard: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
October 10, 2012DrugsFDA
Mylan Pharmaceuticals Inc. recalls Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC
Hazard: Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
October 3, 2012DrugsFDA
Mylan Pharmaceuticals Inc. recalls Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, W
Hazard: Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.