FDA Recall
Terminated
Historical recordClass II
Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
by Gordon Laboratories
- Reason
- Superpotent Drug: contains higher levels of Iron than labeled.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
by Tris Pharma Inc.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
by Tris Pharma Inc.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
by Tris Pharma Inc.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
by PharMEDium Services, LLC
- Reason
- Sub-potent
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
by PharMEDium Services, LLC
- Reason
- Sub-potent
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
by Epic Pharma, LLC
- Reason
- Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Mai Tai, Orange Pineapple, 16…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Spicy Watermelon, Watermelon,…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Beetnik, Orange, Red Beet, Ka…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Seasonal Blend, 16 FL OZ, Man…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Spicy Ginger, 16 FL OZ, Manuf…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Merc Blend, 16 FL OZ, Manufac…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Clean & Clear, Pineapple, Gre…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, Reset, Carrot, Apple, Ginger,…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Luckyberry
- Product
- Luckyberry Cold-Pressed Juice, NoCoast, Kale, Cucumber, Gree…
- Reason
- The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Published
- December 26, 2018
- Distribution
- To retailers in Lawrence, KS.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Marich Confectionery Company, Inc.
- Product
- Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992…
- Reason
- Firm was notified by a direct customer that milk chocolate macadamia nuts were found in their shipment of milk chocolate maltballs.
- Published
- December 26, 2018
- Distribution
- CA, CO, HI, ID, IL, IN, KS, MA, MI, MN.…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- 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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