FDA Recall
OngoingHistorical recordClass II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
by Cardinal Health Inc.
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
by Direct Rx
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
by Direct Rx
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
by Alembic Pharmaceuticals Limited
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
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.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #2485 Assorted layer cake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #99273 chocolate Tres Leches Cheesecake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #3145 Hummingbird Layer Cake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #99272 Tres Leches Cheesecake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #1312 Carrot layer cake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2026Historical recordClass I
King Cheesecake Company, Inc.
- Product
- Item #1071 Italian layer cake
- Reason
- Pecans have the potential to be contaminated with Salmonella
- Published
- August 13, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Doehler North America, Inc.
- Product
- Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.3…
- Reason
- Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
- Published
- August 13, 2025
- Distribution
- Product was shipped to the following: Di…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended u…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
CompletedTerminated: September 11, 2026Historical recordClass I
Navarro Pecan Holdings, LLC
- Product
- FANCY MEDIUM PECAN PIECES 81124 561958 554707 6/13/2025 SDC1…
- Reason
- Pecans have the potential to be contaminated with Salmonella,
- Published
- August 13, 2025
- Distribution
- TX, MN, OK, AR, NJ; UAE, Netherlands, It…
View recall →
FDA Recall
OngoingHistorical recordClass II
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
by Nostrum Laboratories, Inc.
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
by Strides Pharma, Inc.
- Reason
- Failed Dissolution Specifications.
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
by Pfizer Inc.
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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