FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
Moonstruck Chocolate Company
- Product
- Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocol…
- Reason
- Undeclared milk.
- Published
- March 25, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 11, 2020Historical recordClass II
Dreyers Grand Ice Cream, Inc.
- Product
- Outshine Fruit Bars - Variety Pack (contains 24 x 5 oz. unit…
- Reason
- Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.
- Published
- March 25, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 11, 2020Historical recordClass II
Dreyers Grand Ice Cream, Inc.
- Product
- Outshine Fruit Bars Pineapple; 6 Fruit Ice Bars; 6x2 5 fl.…
- Reason
- Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.
- Published
- March 25, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 11, 2020Historical recordClass II
Dreyers Grand Ice Cream, Inc.
- Product
- Outshine Fruit Bars Strawberry; 6 Fruit Ice Bars; 14.7 Fl.…
- Reason
- Firm has received consumer complaints of pieces of white plastic in frozen fruit bars.
- Published
- March 25, 2020
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL,…
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FDA Recall
TerminatedTerminated: May 25, 2021Historical recordClass II
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 25, 2021Historical recordClass III
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 17, 2024Historical recordClass II
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
by H J Harkins Company Inc dba Pharma Pac
- Reason
- Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 17, 2022Historical recordClass II
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
by Precision Dose Inc.
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 4, 2022Historical recordClass II
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
by American Health Packaging
- Reason
- CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2022Historical recordClass III
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
by The Harvard Drug Group
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 28, 2021Historical recordClass II
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
by Mayne Pharma Inc
- Reason
- Product Mix-Up: A foreign tablet was found in bottle.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 1, 2020Historical recordClass II
Les Chateaux De France
- Product
- Butterfly Shrimp 16/20, 50 lb. cases
- Reason
- During a routine inspection, FDA identified the coconut ingredient in the firm's coconut shrimp had undeclared sodium metabisulfite
- Published
- March 18, 2020
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass II
GARZA FOOD VENTURES
- Product
- Siete Grain Free Burrito Size Tortillas Net Wt 15 oz (423g)…
- Reason
- Sodium level in the product 340 mg per serving, instead of the 15 mg declared on the label.
- Published
- March 18, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- William R Hill brand Soup Base Chicken, Item #41178, 1 lb, m…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- MJ Kellner brand Milk Replacer, Vegan, Soy Based, Item #8028…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- Shaver Foods brand Gravy Chicken, Item #35213, in 2 lb. meta…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 12, 2021Historical recordClass II
Tova Industries Inc
- Product
- Shaver Foods brand Gravy Beef, Item #35089, in 2 lb. metalli…
- Reason
- Downstream recall from supplier. Possible metal shavings in ingredient.
- Published
- March 18, 2020
- Distribution
- Products were distributed to the followi…
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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