FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), 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
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
Terminated
Historical 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
Terminated
Historical 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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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
Terminated
Historical 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
Terminated
Historical 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…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kim-Seng Company
- Product
- "***SUPER***BRAND***DRIED CINNAMON POWDER***Net Wt: 4oz(113g…
- Reason
- Elevated lead > 2ppm
- Published
- December 18, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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 →
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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