FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Northern Food I/E Inc.
- Product
- "Lukai sweetened jujube"; 8.3 ounces; red and yellow packagi…
- Reason
- Product contains undeclared sulfites (17.9mg/serving).
- Published
- January 4, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wismettac Asian Foods, Inc.
- Product
- Premium Quality Shirakiku Fish Sausage Jalapeno Net wt. 9.8…
- Reason
- Undeclared collagen (bovine dermis) casing
- Published
- January 4, 2023
- Distribution
- U.S. distribution to the following: - CA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wismettac Asian Foods, Inc.
- Product
- Premium Quality Shirakiku Fish Sausage Original Net wt. 9.8…
- Reason
- Undeclared collagen (bovine dermis) casing
- Published
- January 4, 2023
- Distribution
- U.S. distribution to the following: - CA…
View recall →
FDA Recall
Terminated
Historical recordClass II
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of foreign substance
- Published
- December 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tri-Union Frozen Products Inc
- Product
- King Oscar Anchovies Flat Fillet in Olive Oil 2 oz. can 18 c…
- Reason
- Anchovies found to have elevated levels of histamine
- Published
- December 28, 2022
- Distribution
- Product was distributed to 2 DC's. DOT…
View recall →
FDA Recall
Terminated
Historical recordClass III
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
by Camber Pharmaceuticals, Inc
- Reason
- Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
by Atlantic Management Resources Ltd.
- Reason
- cGMP Deviations
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
- Published
- December 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- December 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bek12 Inc
- Product
- ARASHAN brand mixed dried fruit packaged in 1lb clear plasti…
- Reason
- Undeclared sulfites
- Published
- December 14, 2022
- Distribution
- Product is distributed to Illinois, New…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Betty Buzz LLC
- Product
- Betty Buzz Sparkling Grapefruit - Non-alcoholic Beverage & M…
- Reason
- Beverage has off-odor
- Published
- December 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nestle-USA, Inc. (Corporate Office)
- Product
- Nestle Toll House Edible Chocolate Chip Cookie Dough package…
- Reason
- Potential of foreign material within product.
- Published
- December 14, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GREEN DAY PRODUCE
- Product
- Enoki Mushroom Net wt. 200g (7.05 oz.) 25 units per case UPC…
- Reason
- Product found to be contaminated with Listeria monocytogenes
- Published
- December 14, 2022
- Distribution
- Product was distributed to 18 distributo…
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.