FDA Recall
OngoingHistorical recordClass III
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 18, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 2, 2025Historical recordClass II
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
by LNK International, Inc.
- Reason
- CGMP Deviations: Released product should have been rejected.
- Published
- December 18, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 21, 2025Historical recordClass III
Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3
by Biocompatibles UK, Ltd.
- Reason
- Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
- Published
- December 18, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 21, 2025Historical recordClass II
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's
- Product
- Hungryroot Ricotta Stuffed Shells, 6 packs of 14 oz. each, p…
- Reason
- Products have the potential to be contaminated with Listeria monocytogenes.
- Published
- December 18, 2024
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 21, 2025Historical recordClass II
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's
- Product
- Mama Mancini s Stuffed Shells with Sauce and Mozzarella Chee…
- Reason
- Products have the potential to be contaminated with Listeria monocytogenes.
- Published
- December 18, 2024
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 14, 2025Historical recordClass II
Northern Tier Bakery LLC
- Product
- 7-Eleven Chicken Salad Sandwich, UPC 7 63913-79486 1. Net W…
- Reason
- Tuna salad sandwiches were labeled as chicken salad sandwiches.
- Published
- December 18, 2024
- Distribution
- MN
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Organic Carrots. Bulk 1 pound bags. Washed and ready to pre…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Organic Broccoli Slaw (Salade DE Brocoli), 4Earth Farms, Net…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 p…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Organic Vegetable Medley; Broccoli, Cauliflower, & Carrots.…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Organic Vegetable Medley; Broccoli, Carrots & Cauliflower. W…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Stir Fry Medley; Carrots, Broccoli, Broccoli Stem, Stem. Was…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 23, 2025Historical recordClass I
4 Earth Farms formerly Mcl Fresh Inc
- Product
- Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340…
- Reason
- potential contamination with E. coli O121:H19
- Published
- December 18, 2024
- Distribution
- The firm distributed to seven (7) direct…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 7, 2025Historical recordClass I
Sysco Corporation
- Product
- Cucumber Chunk & Tomato Wedge Item 11835. 2/2.5 lb. Keep…
- Reason
- Cucumbers have the potential to be contaminated with Salmonella.
- Published
- December 18, 2024
- Distribution
- IA, MN, SD, ND, WI. Outside the US to C…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 7, 2025Historical recordClass I
Sysco Corporation
- Product
- Whole and Cut Cucumbers packaged in the following sizes: 1…
- Reason
- Cucumbers have the potential to be contaminated with Salmonella.
- Published
- December 18, 2024
- Distribution
- IA, MN, SD, ND, WI. Outside the US to C…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 24, 2025Historical recordClass II
Deseret Biologicals Inc
- Product
- DesBio lunaSOMM Natural Sleep Support Dietary Supplement ca…
- Reason
- Product contains undeclared soy lecithin.
- Published
- December 18, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 7, 2025Historical recordClass I
CON YEAGER SPICE CO.
- Product
- Con Yeager Spice Company, Trail Bologna Meat Processing Kit,…
- Reason
- Undeclared Allergen - Wheat and Soy
- Published
- December 18, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 27, 2025Historical recordClass II
SUGAR FOODS LLC
- Product
- Fresh Gourmet TORTILLA STRIPS SANTA FE SYTLE NET WT 3.5 OZ (…
- Reason
- Undeclared Wheat. The firm was notified by a consumer that they found crispy onions in the packaging of the tortilla strips. The onions contain wheat which is not listed on the packaging for the tortilla strips.
- Published
- December 18, 2024
- Distribution
- Product was shipped to the following sta…
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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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