FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- Country Oven Cinnamon Roll 4oz, 2.5oz
- Reason
- Downstream Recall - Possible metal fragments in starch that was used to manufacture cakes.
- Published
- November 17, 2021
- Distribution
- Product distributed to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass I
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
by MERCK SHARP & DOHME CORP
- Reason
- Presence of Particulate Matter: Identified as Glass Particles
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Reason
- Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ivar's Commissary
- Product
- Ivar's Kettle Classic Clam Chowder With Uncured Bacon, Item…
- Reason
- Plastic fragments.
- Published
- November 10, 2021
- Distribution
- distributed in Illinois, Indiana, Iowa,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw WHITE onions are imported from Chihuahua of MEXICO…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw YELLOW onions are imported from Chihuahua of MEXIC…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ProSource Produce LLC
- Product
- Whole raw RED onions are imported from Chihuahua of MEXICO.…
- Reason
- Salmonella Oranienburg.
- Published
- November 10, 2021
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NSE Products, Inc.
- Product
- Pharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tab…
- Reason
- Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredient.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Salted Caramel Cre…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Light Cream, 6.5 F…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- 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.
Read the full medical disclaimer.