FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hong Bin Foods LLC
- Product
- Enoki Mushroom; Product of Korea; Net Wt. 7.05 oz., (200 g…
- Reason
- State of Michigan sampled and tested Enoki Mushrooms and found them to be positive for Listeria monocytogenes.
- Published
- April 1, 2020
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
International Sprout Holding Inc.
- Product
- Clover seed in 55 lb. multi-layered white paper bags, 40 bag…
- Reason
- Possible contamination with E. Coli.
- Published
- April 1, 2020
- Distribution
- Product was distributed to the following…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
International Sprout Holding Inc.
- Product
- Clover seed in 50 lb. woven poly bags, 40 bags to a pallet.
- Reason
- Possible contamination with E. Coli.
- Published
- April 1, 2020
- Distribution
- Product was distributed to the following…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
American Classic Snack Co, LLC
- Product
- American Classic Snack Company Sweet Bourbon Crunchers Pretz…
- Reason
- Product is improperly labeled with gluten-free claim.
- Published
- April 1, 2020
- Distribution
- The product was distributed to the follo…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dean Foods, Inc.
- Product
- Baskin Robbins Mint Chocolate Chip, Ice Cream Sandwiches wit…
- Reason
- Undeclared yellow # 5 and blue # 1
- Published
- April 1, 2020
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aseltines
- Product
- Aseltines 100% JUICE Apple Cider 1/2 gallon UPC 5169600064 a…
- Reason
- Product tested positive for patulin in excess of 50 ppb
- Published
- April 1, 2020
- Distribution
- Distributors in MI and IL
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Whole Foods Market Green Chile Chicken Tamale served as a Fa…
- Reason
- Contains undeclared milk
- Published
- April 1, 2020
- Distribution
- Alabama, Arizona, California, Colorado,…
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FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Presence of dark brown discoloration on edges of tablets
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
by Med Man Distribution, Inc.
- Reason
- Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
by Perrigo Company PLC
- Reason
- CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
- Published
- March 25, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- March 25, 2020
- 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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