Morgantown, WV, United States
Mylan Pharmaceuticals Inc. recalls
33 recalls recorded since 2018, most recently on 26 August 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls33
Ongoing (FDA)7
Terminated or completed26
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 26 August 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0830-2026
- Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: M
Ongoing Class II Drugs
- Recall started
- 17 August 2026
- Reason
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Distribution
- Nationwide within the U.S
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0839-2026
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Ongoing Class II Drugs
- Recall started
- 24 July 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0774-2026
- Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
Ongoing Class II Drugs
- Recall started
- 2 July 2026
- Reason
- Presence of precipitate
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0734-2026
- Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND
Ongoing Class II Drugs
- Recall started
- 24 February 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0399-2026
- 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.
Ongoing Class II Drugs
- Recall started
- 25 February 2025
- Reason
- Failed Dissolution Specifications - low dissolution results
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0280-2025
- 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
Terminated Class I Drugs
- Recall started
- 5 July 2022
- Terminated
- 26 February 2024
- Reason
- Labeling: Missing label: Label missing from some prefilled pens.
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1292-2022
- 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 Pharmaceutical
Terminated Class I Drugs
- Recall started
- 12 April 2022
- Terminated
- 18 October 2023
- Reason
- Labeling: Missing label on the vial
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0845-2022
- 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 f
Terminated Class II Drugs
- Recall started
- 7 April 2022
- Terminated
- 23 May 2023
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0774-2022
- 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
Terminated Class II Drugs
- Recall started
- 1 April 2022
- Terminated
- 27 February 2023
- 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 stability testing.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0748-2022
- Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32.
Terminated Class II Drugs
- Recall started
- 21 January 2022
- Terminated
- 12 March 2024
- Reason
- cGMP deficiencies
- Distribution
- Recalled product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0452-2022
- 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.
Terminated Class I Drugs
- Recall started
- 5 January 2022
- Terminated
- 12 January 2024
- Reason
- Labeling: Missing Label: label missing from some Semglee prefilled pens.
- Distribution
- Nationwide in the USA and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0462-2022
- 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 Specia
Terminated Class III Drugs
- Recall started
- 2 October 2020
- Terminated
- 24 January 2022
- Reason
- Out-of-specification organic impurity results obtained during routine stability testing.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0049-2021
- 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 I
Terminated Class III Drugs
- Recall started
- 23 March 2020
- Terminated
- 7 July 2021
- Reason
- Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1057-2020
- Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Terminated Class II Drugs
- Recall started
- 9 March 2020
- Terminated
- 26 May 2021
- Reason
- Presence of particulate matter. presence of metal particles.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1031-2020
- Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Terminated Class II Drugs
- Recall started
- 7 January 2020
- Terminated
- 19 May 2021
- Reason
- CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0791-2020, D-0792-2020
- Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
- Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Terminated Class II Drugs
- Recall started
- 23 October 2019
- Terminated
- 10 December 2020
- Reason
- Presence of Foreign Substance
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0186-2020
- 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
Terminated Class II Drugs
- Recall started
- 18 October 2019
- Terminated
- 10 April 2020
- Reason
- Failed Dissolution Specification: Low out of specification dissolution results.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0155-2020
- Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Terminated Class III Drugs
- Recall started
- 6 September 2019
- Terminated
- 16 July 2020
- Reason
- Failed Impurities/Degradation Specifications:OOS for unknown impurity.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1848-2019
- 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
Terminated Class III Drugs
- Recall started
- 13 February 2019
- Terminated
- 12 September 2019
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
- Distribution
- Throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0506-2019
- 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, 2
Terminated Class II Drugs
- Recall started
- 1 February 2019
- Terminated
- 9 September 2019
- Reason
- Defective Container: Potential for broken glass in the neck area of the glass bottles.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0424-2019
- 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: M
Terminated Class II Drugs
- Recall started
- 18 January 2019
- Terminated
- 9 October 2019
- Reason
- Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0428-2019
- 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.
Terminated Class II Food
- Recall started
- 10 December 2018
- Terminated
- 22 October 2019
- 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 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.
- Distribution
- US Market
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0859-2019, F-0858-2019
- DrNatura Toxinout Kit Broad Spectrum Detoxification Program
- DrNatura Flora Protect¿ Probiotics
Ongoing Class II Drugs
- Recall started
- 20 November 2018
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0312-2019, D-0318-2019, D-0311-2019, D-0316-2019, D-0315-2019, D-0314-2019, D-0317-2019, D-0313-2019
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Terminated Class III Drugs
- Recall started
- 27 August 2018
- Terminated
- 26 July 2019
- Reason
- Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0025-2019
- 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
Terminated Class III Drugs
- Recall started
- 7 August 2018
- Terminated
- 14 August 2019
- Reason
- Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1186-2018, D-1187-2018
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
Terminated Class II Drugs
- Recall started
- 25 July 2018
- Terminated
- 15 August 2019
- Reason
- Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1075-2018
- Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Terminated Class III Drugs
- Recall started
- 9 July 2018
- Terminated
- 16 January 2020
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0978-2018
- Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Terminated Class III Drugs
- Recall started
- 7 June 2018
- Terminated
- 20 June 2019
- Reason
- Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
- Distribution
- Product was distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0877-2018
- Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Terminated Class II Drugs
- Recall started
- 30 April 2018
- Terminated
- 14 February 2019
- Reason
- CGMP Deviations
- Distribution
- Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0830-2018, D-0829-2018, D-0831-2018
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Terminated Class II Drugs
- Recall started
- 24 April 2018
- Terminated
- 20 June 2019
- Reason
- cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
- Distribution
- Product was distributed throughout United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0820-2018, D-0819-2018
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Terminated Class II Drugs
- Recall started
- 24 April 2018
- Terminated
- 14 August 2019
- Reason
- CGMP Deviations
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0825-2018, D-0824-2018
- Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
- Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Terminated Class III Drugs
- Recall started
- 3 November 2017
- Terminated
- 14 June 2018
- 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.
- Distribution
- Product was distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0230-2018
- bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.