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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66403

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 13, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 12

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.

D-66403-001
Recall number
D-66403-001
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
37,752 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 12

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

D-66403-002
Recall number
D-66403-002
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
4,722 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 2003156, 2003157, 2003155, 3043491

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 12

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.

D-66403-003
Recall number
D-66403-003
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
28,140 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 2003194, 2003195; b) 2003193

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 12

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01

D-66403-004
Recall number
D-66403-004
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
521 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 3032075, 3032076

Distribution pattern

Nationwide and Puerto Rico

drug · product 5 of 12

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.

D-66403-005
Recall number
D-66403-005
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
167,866 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot s: a) 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683

Distribution pattern

Nationwide and Puerto Rico

drug · product 6 of 12

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.

D-66403-006
Recall number
D-66403-006
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
30,878 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492

Distribution pattern

Nationwide and Puerto Rico

drug · product 7 of 12

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.

D-66403-007
Recall number
D-66403-007
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
60,506 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493

Distribution pattern

Nationwide and Puerto Rico

drug · product 8 of 12

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

D-66403-008
Recall number
D-66403-008
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
11,701 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 2003184, 2003185, 2003186, 3043495

Distribution pattern

Nationwide and Puerto Rico

drug · product 9 of 12

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.***

D-66403-009
Recall number
D-66403-009
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
42,174 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496

Distribution pattern

Nationwide and Puerto Rico

drug · product 10 of 12

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

D-66403-010
Recall number
D-66403-010
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
23,356 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 2003188, 2003189, 2003190, 2003191, 3043498

Distribution pattern

Nationwide and Puerto Rico

drug · product 11 of 12

Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01

D-66403-011
Recall number
D-66403-011
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
941,270 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046

Distribution pattern

Nationwide and Puerto Rico

drug · product 12 of 12

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.

D-66403-012
Recall number
D-66403-012
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
101,450 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525

Distribution pattern

Nationwide and Puerto Rico