FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mary's Gone Crackers
- Product
- Super Seed Everything Crackers 5.5 oz. UPC: 8 53665 00509 1
- Reason
- May contain foreign object: rubber pieces
- Published
- January 11, 2023
- Distribution
- Product was distributed to 8 distributor…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mary's Gone Crackers
- Product
- Super Seed Classic Crackers (6 pk.) 5.5 oz. UPC: 8 97580 000…
- Reason
- May contain foreign object: rubber pieces
- Published
- January 11, 2023
- Distribution
- Product was distributed to 8 distributor…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cranberry Sweets & More Inc
- Product
- Recalled Meltaways product is packaged in clear cellophane b…
- Reason
- Peanut Butter Meltaway was mis-labeled as Mint Meltaways and peanut is undeclared.
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
by Apotex Corp.
- Reason
- Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
- Published
- January 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062
by NCH Life Sciences LLC
- Reason
- CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
- Published
- January 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
by AVKARE LLC
- Reason
- Failed impurities/degradation specifications: Out of specification for unknown impurities.
- Published
- January 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
- Published
- January 4, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
XO Marshmallow, LLC
- Product
- XO Marshmallow Limited Edition: Banana Puddin' OMG (Ooey Mar…
- Reason
- No label on packaged product
- Published
- January 4, 2023
- Distribution
- AL, AR, CA, FL, GA, IL, IN, KS, KY, LA,…
View recall →
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 II
Phil's Power Pancake
- Product
- Phil's Power Pancakes 5 oz. individually wrapped units 5 var…
- Reason
- Product found to contain wheat that is not declared on the label.
- Published
- January 4, 2023
- Distribution
- Product is distributed in the Los Angele…
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 I
Comercializadora Pepsico Mexico,
- Product
- Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificia…
- Reason
- Potential to contain Salmonella
- Published
- December 28, 2022
- Distribution
- Texas and California
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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
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 →
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.