Drug recall: Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles…

Class II FDA enforcement event 66403. Recall start date: 13 Sep 2013. Status in the FDA record: Terminated. Termination date: 23 Jul 2015.

Reason for recall, in the words of FDA

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Mylan Pharmaceuticals Inc. started this drug recall on 13 Sep 2013. The firm address in the FDA record is in Morgantown, WV. FDA put the recall in Class II. FDA event 66403 has 12 product records. The first FDA enforcement report date is 13 Nov 2013. The record gives the status Terminated, with the termination date 23 Jul 2015.

FDA enforcement report The 12 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and Puerto Rico

Recalling firm

Mylan Pharmaceuticals Inc., Morgantown, WV.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

12 product records in the event.

FDA event 66403: product records
Recall number	Product	Quantity	Class	Status	Report date
D-66403-001	Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	37,752 bottles	Class II	Terminated	13 Nov 2013
D-66403-002	Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01	4,722 bottles	Class II	Terminated	13 Nov 2013
D-66403-003	Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	28,140 bottles	Class II	Terminated	13 Nov 2013
D-66403-004	Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01	521 bottles	Class II	Terminated	13 Nov 2013
D-66403-005	Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	167,866 bottles	Class II	Terminated	13 Nov 2013
D-66403-006	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	30,878 bottles	Class II	Terminated	13 Nov 2013
D-66403-007	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	60,506 bottles	Class II	Terminated	13 Nov 2013
D-66403-008	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01	11,701 bottles	Class II	Terminated	13 Nov 2013
D-66403-009	Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part *Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.*	42,174 bottles	Class II	Terminated	13 Nov 2013
D-66403-010	Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01	23,356 bottles	Class II	Terminated	13 Nov 2013
D-66403-011	Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01	941,270 bottles	Class II	Terminated	13 Nov 2013
D-66403-012	Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.	101,450 bottles	Class II	Terminated	13 Nov 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2013: 370
Share of these events in Class II: 56%
Product records in this event: 12Median of the firm: 1
Events of the firm on the register: 55

Other events of the firm

Other FDA enforcement events of Mylan Pharmaceuticals Inc.
Initiated	Product (first record)	Type	Class	Records
26 Aug 2026	Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured	Drug	Class II	1
17 Aug 2026	Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morganto	Drug	Class II	1
24 Jul 2026	Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufact	Drug	Class II	1
2 Jul 2026	Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: M	Drug	Class II	1
24 Feb 2026	Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My	Drug	Class II	1
25 Feb 2025	Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265	Drug	Class II	1
5 Jul 2022	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packag	Drug	Class I	1
12 Apr 2022	Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside	Drug	Class I	1
7 Apr 2022	Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga	Drug	Class II	1
1 Apr 2022	Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga	Drug	Class II	1

Mylan Pharmaceuticals Inc.: all 55 events

Official channels

FDA enforcement report D-66403-001The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 66403. https://recallregister.com/fda/ii/66403/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and Puerto Rico
What quantity of product is in FDA event 66403?: The event has 12 product records. The first record gives this quantity: 37,752 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2013 have the same class?: 56% of the 370 drug events that started in 2013 are in Class II.