DrugAug 15, 2018
Dymista recall — FDA D-1075-2018
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
Recall history in this database
Classification mix: Class II: 39, Class III: 9, Class I: 3.
DrugJun 20, 2018
Mylan Pharmaceuticals Maxzide-25 recall — FDA D-0877-2018
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 23, 2018
Mylan Pharmaceuticals Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count recall — FDA D-0820-2018
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 23, 2018
Mylan Pharmaceuticals Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count recall — FDA D-0819-2018
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugJan 31, 2018
Mylan Pharmaceuticals bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count recall — FDA D-0230-2018
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine…
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 31, 2017
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack recall — FDA D-0861-2017
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the…
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 31, 2017
Mylan Pharmaceuticals Tarina Fe 1/20 recall — FDA D-0860-2017
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the…
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 5, 2017
Atorvastatin Calcium Tablets, 10 mg* recall — FDA D-0618-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 5, 2017
Atorvastatin Calcium Tablets, 40 mg* recall — FDA D-0620-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 5, 2017
Atorvastatin Calcium Tablets, 20 mg* recall — FDA D-0619-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 5, 2017
Atorvastatin Calcium Tablets, 80 mg* recall — FDA D-0621-2017
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 15, 2015
Mylan Pharmaceuticals Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor recall — FDA D-0435-2015
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Lamotrigine Tablets, USP, 200 mg recall — FDA D-66403-003
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate Tablets, USP 10 mg recall — FDA D-66403-012
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg recall — FDA D-66403-006
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg recall — FDA D-66403-010
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg recall — FDA D-66403-007
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg recall — FDA D-66403-002
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count recall — FDA D-66403-008
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate Tablets, USP, 5 mg recall — FDA D-66403-005
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate Tablets, USP, 2.5 mg recall — FDA D-66403-001
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugNov 13, 2013
Mylan Pharmaceuticals Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 recall — FDA D-66403-009
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugJun 5, 2013
Mylan Pharmaceuticals Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle recall — FDA D-500-2013
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..
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 1, 2013
Mylan Pharmaceuticals Lisinopril Tablets, USP 10 mg recall — FDA D-269-2013
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Mylan Pharmaceuticals Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.