FDA Recall
TerminatedTerminated: November 29, 2022Historical recordClass II
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
by Graviti Pharmaceuticals Private Limited
- Reason
- Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 10, 2020Historical recordClass II
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 10, 2020Historical recordClass II
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 8, 2021Historical recordClass III
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 29, 2021Historical recordClass II
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
by Ascend Laboratories LLC
- Reason
- cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass III
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
by Ascend Laboratories LLC
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution testing.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 2, 2020Historical recordClass II
Golden State Foods
- Product
- Taco Bell Creamy Jalapeno Sauce; GIN: 54973 12/25.5 oz. Po…
- Reason
- Notification by supplier of a recall of starch ingredient due to metal fragments. Ingredient was used in the manufacture of finished products.
- Published
- February 12, 2020
- Distribution
- 4 customers with DC locations in TX, KS,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 2, 2020Historical recordClass II
Golden State Foods
- Product
- Colonel's Coleslaw Dressing; GIN: 0030920 FG: 02612/102186…
- Reason
- Notification by supplier of a recall of starch ingredient due to metal fragments. Ingredient was used in the manufacture of finished products.
- Published
- February 12, 2020
- Distribution
- 4 customers with DC locations in TX, KS,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 2, 2020Historical recordClass II
Golden State Foods
- Product
- Pizza Hut Garlic Dipping Sauce; 144 1.50 oz. cups Net Weig…
- Reason
- Notification by supplier of a recall of starch ingredient due to metal fragments. Ingredient was used in the manufacture of finished products.
- Published
- February 12, 2020
- Distribution
- 4 customers with DC locations in TX, KS,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- White Medium Hard Cooked Eggs sold under the brand names of:…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Smokehouse ProBox Mini White Medium Hard Cooked…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Smokehouse ProBox Cage Free Hard Cooked Eggs
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- White Medium Hard Cooked Eggs w/Salt & Pepper sold under the…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- Vital Farms Pasture Raised Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- Eggland's Best Cage Free Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Cage Free Hard Cooked Eggs w/Salt & Pepper
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Salt & Pepit…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Maple Walnut…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Fried Rice F…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2021Historical recordClass I
Almark Foods, LLC
- Product
- PECKISH PERFECTLY BOILED FREE RANGE ORGANIC Egg Everything B…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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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