Mylan Pharmaceuticals recalls
Mylan Pharmaceuticals appears in 84 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 84 |
|---|---|
| Published | 2012-10-03 to 2026-09-09 |
| By agency | FDA Drug (82), FDA Food (2) |
| By classification | Class II (62), Class III (19), Class I (3) |
| By status | terminated (70), ongoing (14) |
| Distribution named in notices | KY, US |
Recalls
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made…
FDA Drug · Class II · 2026-09-09 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria - Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institu…
FDA Drug · Class II · 2026-09-09 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications - Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pha…
FDA Drug · Class II · 2026-08-26 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications - Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional…
FDA Drug · Class II · 2026-08-05 · Mylan Pharmaceuticals
Reason: Presence of precipitate - Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals…
FDA Drug · Class II · 2026-03-11 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications - Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378…
FDA Drug · Class II · 2025-03-26 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications - low dissolution results - Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5…
FDA Drug · Class I · 2022-08-03 · Mylan Pharmaceuticals
Reason: Labeling: Missing label: Label missing from some prefilled pens. - Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only,…
FDA Drug · Class I · 2022-05-04 · Mylan Pharmaceuticals
Reason: Labeling: Missing label on the vial - Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S…
FDA Drug · Class II · 2022-04-27 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. - Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, ND…
FDA Drug · Class II · 2022-04-13 · Mylan Pharmaceuticals
Reason: 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 stab… - Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by…
FDA Drug · Class II · 2022-02-02 · Mylan Pharmaceuticals
Reason: cGMP deficiencies - Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens pe…
FDA Drug · Class I · 2022-01-26 · Mylan Pharmaceuticals
Reason: Labeling: Missing Label: label missing from some Semglee prefilled pens. - Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-cou…
FDA Drug · Class III · 2020-10-28 · Mylan Pharmaceuticals
Reason: Out-of-specification organic impurity results obtained during routine stability testing. - Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
FDA Drug · Class III · 2020-04-01 · Mylan Pharmaceuticals
Reason: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. - Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2020-03-25 · Mylan Pharmaceuticals
Reason: Presence of particulate matter. presence of metal particles. - Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93
FDA Drug · Class II · 2020-01-29 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. - Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91
FDA Drug · Class II · 2020-01-29 · Mylan Pharmaceuticals
Reason: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. - Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2019-11-13 · Mylan Pharmaceuticals
Reason: Presence of Foreign Substance - Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2019-11-06 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specification: Low out of specification dissolution results. - Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505
FDA Drug · Class III · 2019-09-18 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications:OOS for unknown impurity. - Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378…
FDA Drug · Class III · 2019-02-27 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing - DrNatura Toxinout Kit Broad Spectrum Detoxification Program
FDA Food · Class II · 2019-02-20 · Mylan Pharmaceuticals
Reason: 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 DrNatura Toxinout Kit lot 0059… - DrNatura Flora Protect¿ Probiotics
FDA Food · Class II · 2019-02-20 · Mylan Pharmaceuticals
Reason: 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 being recalled due to undeclared… - Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weig…
FDA Drug · Class II · 2019-02-13 · Mylan Pharmaceuticals
Reason: Defective Container: Potential for broken glass in the neck area of the glass bottles. - 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)
FDA Drug · Class II · 2019-02-06 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. - Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmac…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 2650…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 2650…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 2650…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.…
FDA Drug · Class II · 2018-12-19 · Mylan Pharmaceuticals
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the 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…
FDA Drug · Class III · 2018-10-24 · Mylan Pharmaceuticals
Reason: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. - Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc
FDA Drug · Class III · 2018-09-19 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. - Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc
FDA Drug · Class III · 2018-09-19 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. - Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight,…
FDA Drug · Class II · 2018-08-15 · Mylan Pharmaceuticals
Reason: Presence of foreign substance: Potential for glass in the neck area of the glass bottles. - Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc
FDA Drug · Class III · 2018-07-18 · Mylan Pharmaceuticals
Reason: Subpotent Drug - Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morga…
FDA Drug · Class III · 2018-06-20 · Mylan Pharmaceuticals
Reason: Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. - Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals
Reason: CGMP Deviations - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals
Reason: CGMP Deviations - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals
Reason: CGMP Deviations - PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals
Reason: CGMP Deviations - Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
FDA Drug · Class II · 2018-05-30 · Mylan Pharmaceuticals
Reason: CGMP Deviations - Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
FDA Drug · Class II · 2018-05-23 · Mylan Pharmaceuticals
Reason: cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure - Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
FDA Drug · Class II · 2018-05-23 · Mylan Pharmaceuticals
Reason: cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure - bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc
FDA Drug · Class III · 2018-01-31 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing. - Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
FDA Drug · Class III · 2017-06-21 · Mylan Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities - Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morg…
FDA Drug · Class II · 2017-05-31 · Mylan Pharmaceuticals
Reason: Failed Dissolution Specifications - Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged i…
FDA Drug · Class III · 2017-05-31 · Mylan Pharmaceuticals
Reason: 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 manufacturing room.