FDA Recall
Ongoing
Historical recordClass II
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
by Eugia US LLC
- Reason
- Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
- Published
- January 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tai Phat Wholesalers LLC
- Product
- Three Gold Coins, Dried Mushrooms (01277) Nam Meo Nguyen T…
- Reason
- Products were found to be contaminated with Salmonella.
- Published
- January 11, 2023
- Distribution
- The product was distributed to consignee…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tai Phat Wholesalers LLC
- Product
- Three Gold Coins, Dried Mushrooms (01052) Nam Meo Nguyen T…
- Reason
- Products were found to be contaminated with Salmonella.
- Published
- January 11, 2023
- Distribution
- The product was distributed to consignee…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tai Phat Wholesalers LLC
- Product
- Three Gold Coins, Dried Mushrooms Sliced (01276) Nam Meo S…
- Reason
- Products were found to be contaminated with Salmonella.
- Published
- January 11, 2023
- Distribution
- The product was distributed to consignee…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tai Phat Wholesalers LLC
- Product
- Three Gold Coins, Dried Mushrooms Sliced (01051) Nam Meo S…
- Reason
- Products were found to be contaminated with Salmonella.
- Published
- January 11, 2023
- Distribution
- The product was distributed to consignee…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Four Seasons Produce Warehouse #2/Sunrise Logistics, Inc
- Product
- PROPAL, Hass Avocados , Bag of 6 pieces, Green net with gree…
- Reason
- Sunrise Logistics Inc/ Four Seasons Produce Inc, 400 Wabash , Road Ephrata, PA 17522 has initiated a recall of, PROPAL Hass Avocados, Bag of 6 pieces, Green net with green plastic film, 11 bags per case because they were found to be contaminated with pesticides as per tolerance limit 40CFR 180.275.
- Published
- January 11, 2023
- Distribution
- The product was distributed to two consi…
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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
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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
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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
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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 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 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 →
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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