FoodJun 19, 2019
COOLHAUS Cool Haus Awesome Dessert - Dairy Free Horchata Frozen Dessert recall — FDA F-1445-2019
Product contains undeclared milk
Class IFDA: TerminatedCOOLHAUS
June 2019 recalls — page 5
These records include useful source details for the selected month.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE BLACK CHOCOLATE MEIJI, 1.75 oz recall — FDA F-1450-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE MACADAMIA MEIJI, 2.25 oz recall — FDA F-1452-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE TAKENOKO NO SATO MEIJI recall — FDA F-1454-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE KINOKO NO YAMA MEIJI, 2.61 oz recall — FDA F-1453-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE CHOCO BABY recall — FDA F-1455-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
FoodJun 19, 2019
LAIRD SUPERFOOD Performance Mushrooms product is dried mushroom blend of 4 recall — FDA F-1456-2019
The product is incorrectly labeled with 14 mg of Iron and 78% DV when the actual amount is 14 mcg of Iron and 0% DV.
Class IIIFDA: TerminatedLAIRD SUPERFOOD Inc.
FoodJun 19, 2019
Wismettac Asian Foods CHOCOLATE ALMOND CHOCOLATE MEIJI, 3.1 oz recall — FDA F-1451-2019
Some chocolate products imported from Japan do not have the English label for Nutrition facts, ingredients or allergens, which include milk, soy, egg, tree nuts.
Class IIFDA: TerminatedWismettac Asian Foods, Inc.
DrugJun 19, 2019
Torrent Pharma Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton recall — FDA D-1357-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough recall — FDA D-1356-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. recall — FDA D-1354-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol recall — FDA D-1347-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial recall — FDA D-1397-2019
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class IFDA: TerminatedHeritage Pharmaceuticals, Inc.
DrugJun 19, 2019
Torrent Pharma Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL recall — FDA D-1360-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Phenobarbital Oral Solution, USP, 20 mg per 5 mL recall — FDA D-1365-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Robafen DM Syrup recall — FDA D-1351-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. recall — FDA D-1370-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD recall — FDA D-1361-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Robafen DM Cough Sugar-Free Clear Cough Expectorant recall — FDA D-1355-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only recall — FDA D-1381-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Estradiol Vaginal Inserts USP 10 mcg recall — FDA D-1340-2019
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugJun 19, 2019
Torrent Pharma Lactulose Solution, USP 10 g/15 mL, For Oral Administration recall — FDA D-1372-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Guaifenesin AC Cough Syrup recall — FDA D-1363-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugJun 19, 2019
Torrent Pharma Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL recall — FDA D-1358-2019
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class IIFDA: TerminatedTorrent Pharma Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.