FDA Recall
OngoingHistorical recordClass II
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
by Viatris Inc
- Reason
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Published
- December 18, 2024
- Distribution
- Nationwide
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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
OngoingHistorical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
by FDC Limited
- Reason
- Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- Published
- December 18, 2024
- Distribution
- Distributed to one Us Distributor in NJ.
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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: April 1, 2025Historical recordClass I
F&S Produce West LLC
- Product
- Mediterranean Inspired Party Tray; Sell by dates 11/27/2024-…
- Reason
- Mediterranean party tray contains tzatziki sauce made with potentially contaminated (Salmonella) cucumbers.
- Published
- December 18, 2024
- Distribution
- 187 retail locations in AZ, CA, ID, MT,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 30, 2025Historical recordClass II
House Of Flavors, Inc.
- Product
- Giant Eagle churned Butter Pecan Reduced Fat 48FLOZ, UPC 030…
- Reason
- Undeclared soy (soy lecithin).
- Published
- December 18, 2024
- Distribution
- Retail stores in MD, OH, PA, and WV
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 13, 2024Historical recordClass II
Piazza Produce (dba CIBUS Fresh)
- Product
- CIBUS Fresh, Jack & Olive, Sprig and Sprout branded Autumn T…
- Reason
- Spreadable brie, 2/3lb used in sandwich was recalled by manufacturer due to possible Listeria monocytogenes contamination
- Published
- December 18, 2024
- Distribution
- IL IN KY MO OH TN
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FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Tipp Distributors, Inc. dba Novamex
- Product
- Jarritos Coconut Water 17.5 fl oz cans- 12 cans per carton
- Reason
- The hermetic seal on the lid of the cans may be compromised
- Published
- December 18, 2024
- Distribution
- Only in the US. States: AL, AR, DE, FL,…
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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
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
NESTLE HEALTH SCIENCE
- Product
- Nestle Health Services Nutren 2.0 kCal/mL, Calorically Dense…
- Reason
- Labeling Error. Nutren 2.0 UltraPak pouches were mislabeled with an Isosource 1.5 label.
- 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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FDA Recall
TerminatedTerminated: June 27, 2025Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
by Lannett Company Inc.
- Reason
- Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- Published
- December 11, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
by AvKARE
- Reason
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
by AvKARE
- Reason
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
by AvKARE
- Reason
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Published
- December 11, 2024
- 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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