FDA Recall
Ongoing
Historical recordClass II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
by Amerisource Health Services LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- January 22, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
by Alcon Research LLC
- Reason
- Non-Sterility
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Eclectic Institute Inc
- Product
- Eclectic Herb Vitamin Herb Blend vita biotic dietary supplem…
- Reason
- Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
by Jubilant Draximage Inc., dba Jubilant Radiopharma
- Reason
- Failed Stability Specifications
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
by Granules Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
by Eugia US LLC
- Reason
- Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
by Eugia US LLC
- Reason
- CGMP Deviations
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
by Amerisource Health Services LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
by West-Ward Columbus Inc
- Reason
- Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
by FDC Limited
- Reason
- Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
- Published
- January 15, 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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