FDA Recall
Ongoing
Historical recordClass II
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
by PFIZER INC
- Reason
- Lack of Assurance of Sterility.
- Published
- August 27, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
by PFIZER INC
- Reason
- Lack of Assurance of Sterility.
- Published
- August 27, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Khee Trading, Inc.
- Product
- Product is Frozen Half Shell Oysters in 15 pound blacks. Pac…
- Reason
- Imported Frozen Oyster potentially contaminated with Norovirus.
- Published
- August 27, 2025
- Distribution
- Distribution is 8 distributor consignees…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Khee Trading, Inc.
- Product
- Product is Frozen Half Shell Oysters in 15 pound blacks. Pac…
- Reason
- Imported Frozen Oyster potentially contaminated with Norovirus.
- Published
- August 27, 2025
- Distribution
- Distribution is 8 distributor consignees…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SRI SRI TATTVA
- Product
- Sri Sri Tattva, Ojasvita Chocomalt,7oz / 200g, Paper Pouch,…
- Reason
- Product contains undeclared soy lecithin.
- Published
- August 27, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kobayashi Noodle U.S.A.
- Product
- Product is distributed in 10lb bulk packaging. Brown cardboa…
- Reason
- Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
- Published
- August 27, 2025
- Distribution
- CA
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kobayashi Noodle U.S.A.
- Product
- Product is distributed in 10lb bulk packaging. Brown cardboa…
- Reason
- Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
- Published
- August 27, 2025
- Distribution
- CA
View recall →
FDA Recall
Ongoing
Historical recordClass II
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
by Merck & Co. Inc
- Reason
- Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
by Westminster Pharmaceuticals LLC
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
by Westminster Pharmaceuticals LLC
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications: low dissolution results
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Jayone Foods, Inc.
- Product
- Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name:…
- Reason
- Frozen Oyster product is potentially contaminated with Norovirus
- Published
- August 20, 2025
- Distribution
- Distribution is limited to 1 wholesale d…
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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