thejoe Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc.: 78 FDA recall reports

Every drug recall the FDA has published for Mylan Pharmaceuticals Inc.. The fault, and how the agency graded it.

78Reports

3Class I

10Ongoing

2026-03-11Most recent

3 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	56
Class III	19
Class I	3

By year reported

Year	Reports
2012	3
2013	16
2014	4
2015	2
2016	2
2017	10
2018	22
2019	6
2020	5
2022	6
2025	1
2026	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactur

D-0399-2026 · Class II · reported 2026-03-11 · Ongoing

Why it was recalled: Failed Dissolution Specifications
Product: Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Where it went: Nationwide within the United States
How much: 34850 blister packs

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morganto

D-0280-2025 · Class II · reported 2025-03-26 · Ongoing

Why it was recalled: Failed Dissolution Specifications - low dissolution results
Product: Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Where it went: US Nationwide.
How much: N/A

Class I

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-7

D-1292-2022 · Class I · reported 2022-08-03 · Terminated

Why it was recalled: Labeling: Missing label: Label missing from some prefilled pens.
Product: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Where it went: Product was distributed nationwide within the United States
How much: 253,200 pens (50,650/5 per packs)

Class I

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vi

D-0845-2022 · Class I · reported 2022-05-04 · Terminated

Why it was recalled: Labeling: Missing label on the vial
Product: Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80
Where it went: USA nationwide.
How much: 89,665 vials

Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional

D-0774-2022 · Class II · reported 2022-04-27 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Product: Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Where it went: Nationwide in the USA
How much: 33,893 vials

Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals I

D-0748-2022 · Class II · reported 2022-04-13 · Terminated

Why it was recalled: Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Product: Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Where it went: Nationwide in the USA and Puerto Rico
How much: 20,112 bottles

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol contai

D-0452-2022 · Class II · reported 2022-02-02 · Terminated

Why it was recalled: cGMP deficiencies
Product: Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.
Where it went: Recalled product was distributed nationwide within the United States.
How much: 233,199/10 g aerosol containers

Class I

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged i

D-0462-2022 · Class I · reported 2022-01-26 · Terminated

Why it was recalled: Labeling: Missing Label: label missing from some Semglee prefilled pens.
Product: Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Where it went: Nationwide in the USA and Thailand.
How much: 73,175 prefilled pens

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC

D-0049-2021 · Class III · reported 2020-10-28 · Terminated

Why it was recalled: Out-of-specification organic impurity results obtained during routine stability testing.
Product: Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Where it went: Nationwide within the United States
How much: 10,695 bottles

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC

D-1057-2020 · Class III · reported 2020-04-01 · Terminated

Why it was recalled: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Product: Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Where it went: U.S.A. Nationwide
How much: 3,816 botlles

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 265

D-1031-2020 · Class II · reported 2020-03-25 · Terminated

Why it was recalled: Presence of particulate matter. presence of metal particles.
Product: Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Where it went: Distributed Nationwide in the USA
How much: 300 100-count bottles

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

D-0791-2020 · Class II · reported 2020-01-29 · Terminated

Why it was recalled: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Product: Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Where it went: Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
How much: 31,736 bottles of 60 capsules

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

D-0792-2020 · Class II · reported 2020-01-29 · Terminated

Why it was recalled: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Product: Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Where it went: Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
How much: 16,944 bottles of 30 capsules

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morga

D-0186-2020 · Class II · reported 2019-11-13 · Terminated

Why it was recalled: Presence of Foreign Substance
Product: Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
Where it went: Nationwide within the United States
How much: 5,760 bottles

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV

D-0155-2020 · Class II · reported 2019-11-06 · Terminated

Why it was recalled: Failed Dissolution Specification: Low out of specification dissolution results.
Product: Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Where it went: Nationwide within the United States
How much: 4,272 bottles

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morg

D-1848-2019 · Class III · reported 2019-09-18 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Product: Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Where it went: Nationwide in the USA
How much: 13,157 5 mL bottles

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b

D-0506-2019 · Class III · reported 2019-02-27 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Product: Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Where it went: Throughout the United States
How much: 8,159 bottles

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Meter

D-0424-2019 · Class II · reported 2019-02-13 · Terminated

Why it was recalled: Defective Container: Potential for broken glass in the neck area of the glass bottles.
Product: Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
Where it went: Nationwide in the USA.
How much: 10,390 bottles

Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bot

D-0428-2019 · Class II · reported 2019-02-06 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Product: Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Where it went: Nationwide in the USA
How much: 88,090 bottles

Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:

D-0312-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.
Where it went: Product was distributed throughout the United States.
How much: 12,336 bottles

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for

D-0318-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Where it went: Product was distributed throughout the United States.
How much: 48,302 bottles

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:

D-0311-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.
Where it went: Product was distributed throughout the United States.
How much: 23,478 bottles

Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica

D-0316-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.
Where it went: Product was distributed throughout the United States.
How much: 25,147 bottles

Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutical

D-0315-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
Where it went: Product was distributed throughout the United States.
How much: 63,213 bottles

Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica

D-0314-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.
Where it went: Product was distributed throughout the United States.
How much: 12,840 bottles

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Ma

D-0317-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Where it went: Product was distributed throughout the United States.
How much: 5,660 bottles

Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica

D-0313-2019 · Class II · reported 2018-12-19 · Ongoing

Why it was recalled: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Product: Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.
Where it went: Product was distributed throughout the United States.
How much: 24,709 bottles

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs con

D-0025-2019 · Class III · reported 2018-10-24 · Terminated

Why it was recalled: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Product: Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
Where it went: Product was distributed throughout the United States.
How much: 5,790 cartons (526,890 tablets)

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morg

D-1186-2018 · Class III · reported 2018-09-19 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Product: Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Where it went: Distributed Nationwide in the US
How much: 11,799 bottles of 100

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morg

D-1187-2018 · Class III · reported 2018-09-19 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Product: Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
Where it went: Distributed Nationwide in the US
How much: 656 500-count bottles

Showing the 30 most recent of 78. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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