DrugSep 9, 2026
MYCOPHENOLATE MOFETIL Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial recall — FDA D-0830-2026
Failed Dissolution Specifications
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
Recall history in this database
Classification mix: Class II: 39, Class III: 9, Class I: 3.
DrugAug 5, 2026
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton recall — FDA D-0734-2026
Presence of precipitate
Class IIFDA: OngoingMYLAN PHARMACEUTICALS Inc.
DrugAug 3, 2022
Mylan Pharmaceuticals Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL recall — FDA D-1292-2022
Labeling: Missing label: Label missing from some prefilled pens.
Class IFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 4, 2022
Mylan Pharmaceuticals Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL recall — FDA D-0845-2022
Labeling: Missing label on the vial
Class IFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 27, 2022
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton recall — FDA D-0774-2022
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugApr 13, 2022
Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle recall — FDA D-0748-2022
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance…
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugJan 26, 2022
Mylan Pharmaceuticals Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL recall — FDA D-0462-2022
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class IFDA: TerminatedMylan Pharmaceuticals Inc.
DrugOct 28, 2020
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg recall — FDA D-0049-2021
Out-of-specification organic impurity results obtained during routine stability testing.
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugJan 29, 2020
Mylan Pharmaceuticals Nizatidine Capsules, USP 150 mg recall — FDA D-0791-2020
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugJan 29, 2020
Mylan Pharmaceuticals Nizatidine Capsules, USP 300 mg recall — FDA D-0792-2020
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugFeb 27, 2019
Mylan Pharmaceuticals Diltiazem HCl Extended-Release Capsules, USP 180mg recall — FDA D-0506-2019
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Class IIIFDA: TerminatedMylan Pharmaceuticals Inc.
FoodFeb 20, 2019
Mylan Pharmaceuticals DrNatura Toxinout Kit Broad Spectrum Detoxification Program recall — FDA F-0859-2019
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18…
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
FoodFeb 20, 2019
Mylan Pharmaceuticals DrNatura Flora Protect Probiotics recall — FDA F-0858-2019
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are…
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugFeb 13, 2019
Dymista recall — FDA D-0424-2019
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugFeb 6, 2019
Mylan Pharmaceuticals Fexofenadine HCl Tablets, USP, 180 mg recall — FDA D-0428-2019
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle recall — FDA D-0312-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle recall — FDA D-0318-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle recall — FDA D-0311-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Valsartan Tablets, USP, 320 mg, 90-count bottle recall — FDA D-0316-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Valsartan Tablets, USP, 40 mg, 30-count bottle recall — FDA D-0315-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Valsartan Tablets, USP, 160 mg, 90-count bottle recall — FDA D-0314-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle recall — FDA D-0317-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugDec 19, 2018
Valsartan Tablets, USP, 80 mg, 90-count bottles recall — FDA D-0313-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class IIFDA: OngoingMylan Pharmaceuticals Inc.
DrugOct 24, 2018
Mylan Pharmaceuticals Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg recall — FDA D-0025-2019
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
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.