Duloxetine Capsule, Delayed Release Pellets
FDA Recall NDC 51991-747
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 19 recorded enforcement report(s) associated with Duloxetine (NDC 51991-747). A significant event, classified as Class II, was initiated on Apr 21, 2026 by Breckenridge Pharmaceutical, Inc.. The reported reason for this action was: "CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
D-0522-2026D-0216-2026D-0100-2026D-0552-2025D-0511-2025D-0387-2025D-0388-2025D-0308-2025D-0271-2025D-0270-2025D-0269-2025D-0162-2025D-0161-2025D-0009-2025D-0562-2024D-0483-2024D-0484-2024D-0482-2024D-0181-2016
April 2026 Class II Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Apr 21, 2026
May 13, 2026
165,761 90-count bottles
Recall Profile & Regulatory Data
Event ID
98803
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Batch or Lot Expiration Information
Lot# Lot: 241069C, Exp 05/31/2027
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
November 2025 Class II Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall Number
Class II Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Nov 24, 2025
Dec 10, 2025
7389 bottles
Recall Profile & Regulatory Data
Event ID
98034
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Batch or Lot Expiration Information
Lot# : 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Oct 09, 2025
Nov 05, 2025
172,263 bottles
Recall Profile & Regulatory Data
Event ID
97797
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Batch or Lot Expiration Information
Lot# 90-count-
Lot# 240721C; Exp. 02/28/2027 1000-count-
Lot# 230286C; Exp.02/28/2026
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Jul 15, 2025
Aug 13, 2025
1,829 60-count bottles
Recall Profile & Regulatory Data
Event ID
97276
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Batch or Lot Expiration Information
Lot# Lot: 230836C, Exp.: 02/28/2026
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Jun 30, 2025
Jul 16, 2025
12,242 30-count bottles
Recall Profile & Regulatory Data
Event ID
97179
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Batch or Lot Expiration Information
Lot# 230199, Exp. Date 01/31/2026
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Apr 14, 2025
Apr 30, 2025
16,473 bottles
Recall Profile & Regulatory Data
Event ID
96707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Batch or Lot Expiration Information
Lot# 240987C, exp. date 04/2027 241014C, exp. date 04/2027
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Apr 14, 2025
Apr 30, 2025
343,344 bottles
Recall Profile & Regulatory Data
Event ID
96707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Batch or Lot Expiration Information
Lot# 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Mar 26, 2025
Apr 09, 2025
14,863 bottles
Recall Profile & Regulatory Data
Event ID
96582
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
Batch or Lot Expiration Information
Lot# Lot 240909C, Exp Date 03/31/2027
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Feb 28, 2025
Mar 19, 2025
11,125 bottles.
Recall Profile & Regulatory Data
Event ID
96380
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Batch or Lot Expiration Information
Lot# : 240098C, Expiration: 01/2027.
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Feb 28, 2025
Mar 19, 2025
14,749 bottles.
Recall Profile & Regulatory Data
Event ID
96380
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Batch or Lot Expiration Information
Lot# : 240225C, Expiration: 01/2027
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Feb 28, 2025
Mar 19, 2025
11,100 bottles.
Recall Profile & Regulatory Data
Event ID
96380
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
Batch or Lot Expiration Information
Lot# : 240301C, Expiration: 01/2027.
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Dec 06, 2024
Jan 01, 2025
76,968 bottles
Recall Profile & Regulatory Data
Event ID
95853
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Batch or Lot Expiration Information
Lot# 230077C, exp. date 11/2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Dec 06, 2024
Jan 01, 2025
163,883 bottles
Recall Profile & Regulatory Data
Event ID
95853
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Batch or Lot Expiration Information
Lot# 222205C, exp. date 11/2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Completed
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Oct 10, 2024
Oct 23, 2024
7,107 bottles
Recall Profile & Regulatory Data
Event ID
95508
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Batch or Lot Expiration Information
Lot# : 220128, Exp. Date 12/2024
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Terminated
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
May 17, 2024
Jun 26, 2024
165,678, 90-count bottles
Recall Profile & Regulatory Data
Event ID
94611
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 07, 2026
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Batch or Lot Expiration Information
Lot# : 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Apr 29, 2024
May 15, 2024
7,188/ 500 count bottles
Recall Profile & Regulatory Data
Event ID
94483
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Batch or Lot Expiration Information
Lot# 220456: Exp. Feb 2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Apr 29, 2024
May 15, 2024
281,554/90 count bottles
Recall Profile & Regulatory Data
Event ID
94483
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Batch or Lot Expiration Information
Lot# 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class II Ongoing
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Apr 29, 2024
May 15, 2024
281,554/90 & 1000 count bottles
Recall Profile & Regulatory Data
Event ID
94483
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Batch or Lot Expiration Information
Lot# 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
Class III Terminated
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Oct 21, 2015
Nov 18, 2015
595 Bottles
Recall Profile & Regulatory Data
Event ID
72563
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Breckenridge Pharmaceutical, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 24, 2015
Product Description
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Batch or Lot Expiration Information
Lot# : 142391, Exp 10/2016
Affected Packages Involved in this Recall
51991-746-06Product
51991-746-90Product
51991-746-05Product
51991-747-33Product
51991-747-90Product
51991-747-10Product
51991-748-33Product
51991-748-90Product
51991-748-10Product
51991-750-33Product
51991-750-90Product
51991-750-05Product
51991-750-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
