FDA Recall
🇺🇸 United States
TerminatedTerminated: August 29, 2019Historical recordClass III
Twenty-First Century Healthcare, Inc
- Product
- Good Neighbor Pharmacy, Co Q10 200mg Capsule, Dietary Supple…
- Reason
- 21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 10, 2019Historical recordClass II
Concord Foods, LLC
- Product
- Concord Fresh Success Mild Salsa Seasoning Mix, Packaged in…
- Reason
- Product contains undeclared allergen, milk.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2019Historical recordClass II
Meijer
- Product
- Meijer Ultimate Chocolate Mint Chip Cookie Cookies in clea…
- Reason
- Undeclared soy
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 14, 2020Historical recordClass II
World Waters, LLC dba WTRMLN WTR
- Product
- Watermelon, WTRMLNWTR Cold Pressured, 12fl oz, Watermelon Fl…
- Reason
- Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products.
- Published
- March 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 22, 2020Historical recordClass III
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
- Published
- March 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 7, 2019Historical recordClass II
Threshold Enterprises Ltd
- Product
- Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count,…
- Reason
- Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
- Published
- March 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 14, 2023Historical recordClass I
Puratos Corporation
- Product
- Tegral Satin Gold CL Cr¿me Cake, packaged in 50 lb. bag.
- Reason
- Product contains undeclared milk.
- Published
- March 6, 2019
- Distribution
- Product was distributed in FL, OH, SC, T…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 13, 2019Historical recordClass II
Birdseed Food Co LLC
- Product
- Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz.…
- Reason
- Craft Granola Goldenola Turmeric & Ginger was recalled due to visible undeclared whole cashews
- Published
- March 6, 2019
- Distribution
- CA, CT, MD,NY, OR and PA
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 6, 2019Historical recordClass II
King Orchards
- Product
- Montmorency Tart Cherry Concentrate 100% Juice 32-oz bottl…
- Reason
- Incorrect quantity of sugar listed in Nutrition Facts. Label states 1g sugar per serving when actually 15g per serving.
- Published
- March 6, 2019
- Distribution
- CA, CT, FL, GA, IL, IN, KY, LA, MD, MI,…
View recall →
FDA Recall
TerminatedTerminated: November 3, 2020Historical recordClass III
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
by Akorn Inc
- Reason
- Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 23, 2020Historical recordClass III
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
by ACP Nimble Buyer, Inc.
- Reason
- Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 6, 2020Historical recordClass III
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 8, 2021Historical recordClass III
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
by Perrigo New York, Inc.
- Reason
- Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 29, 2022Historical recordClass II
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
by Akorn Inc
- Reason
- Failed Stability Specification: out of specification results for Sodium Perborate
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 4, 2020Historical recordClass II
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
by ICU Medical Inc
- Reason
- CGMP Deviations
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 24, 2020Historical recordClass II
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
by US Compounding Inc
- Reason
- Lack of assurance of sterility.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 14, 2023Historical recordClass II
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification results observed for high dissolution.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Published
- February 27, 2019
- 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.
Read the full medical disclaimer.
