FDA Recall
OngoingHistorical 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
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FDA Recall
TerminatedTerminated: September 13, 2023Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 8, 2023Historical recordClass I
UTOPIA FOODS INC
- Product
- Utopia brand Enoki Mushroom; Utopia Foods Inc; 200g; Product…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2022
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: March 15, 2024Historical 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
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FDA Recall
TerminatedTerminated: September 20, 2023Historical 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
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FDA Recall
TerminatedTerminated: September 20, 2023Historical 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
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FDA Recall
TerminatedTerminated: September 20, 2023Historical 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
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FDA Recall
TerminatedTerminated: September 20, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 10, 2025Historical 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
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FDA Recall
TerminatedTerminated: October 10, 2025Historical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 2023Historical recordClass II
Weis Markets, Inc., Ice Cream Division
- Product
- Weis Quality Premium Ice Cream Sea Salt Caramel Ripple 1.5 Q…
- Reason
- Undeclared soy and coconut
- Published
- December 14, 2022
- Distribution
- Distributed to retail stores in Pennsylv…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 24, 2023Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 29, 2023Historical 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
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FDA Recall
TerminatedTerminated: August 1, 2024Historical recordClass III
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
- Published
- December 7, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 28, 2024Historical recordClass III
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 7, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 13, 2023Historical recordClass II
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01
by Heritage Pharmaceuticals Inc
- Reason
- Subpotent Drug
- Published
- December 7, 2022
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
- Published
- December 7, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 19, 2023Historical recordClass II
Amys Kitchen Inc
- Product
- Amy's Kitchen Gluten Free Bean and Cheese Burrito 5.5 oz. in…
- Reason
- Product may contain foreign material: pieces of plastic
- Published
- December 7, 2022
- Distribution
- Product was distributed to the following…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 6, 2023Historical recordClass III
Perfect Day Inc
- Product
- Coolhaus Dairy Free Cookie Dough Lyfe Frozen Dessert Sandwic…
- Reason
- Presence of coliform found in 3rd party lab samples
- Published
- December 7, 2022
- Distribution
- Product was shipped only to consignee, K…
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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