FDA Recall
Terminated
Historical recordClass II
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.
by Sanofi-Aventis U.S. LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Kettle Cuisine, LLC
- Product
- Marketside Creamy Cauliflower Parmesan Soup 16 ounce UPC C…
- Reason
- Soup labeled Creamy Cauliflower Parmesan Soup may contain undeclared fish and wheat
- Published
- December 11, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Inc
- Product
- Lamb Weston Grown In Idaho Crispy Hash Brown Dices, packaged…
- Reason
- Crispy Hash Brown Dices product is recalled because it may contain pieces of hard rubber material.
- Published
- December 11, 2019
- Distribution
- distributed in AZ, CA, CO, CT, GA, MA, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Givaudan Flavours Corp
- Product
- Nat Strawberry Banana Flavor WONF, 20.412 kg in each 6 gallo…
- Reason
- Metal material in raw ingredient used during production of liquid flavor product
- Published
- December 11, 2019
- Distribution
- California, Georgia, Illinois, and Michi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Givaudan Flavours Corp
- Product
- Nat Maple Flavor WONF, 20.412 kg in each 6 gallon blue HDPE…
- Reason
- Metal material in raw ingredient used during production of liquid flavor product
- Published
- December 11, 2019
- Distribution
- California, Georgia, Illinois, and Michi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Givaudan Flavours Corp
- Product
- Nat Bacon (smoky) Flavor WONF, 45kg in each 15 gallon blue H…
- Reason
- Metal material in raw ingredient used during production of liquid flavor product
- Published
- December 11, 2019
- Distribution
- California, Georgia, Illinois, and Michi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Givaudan Flavours Corp
- Product
- Nat Cashew Flavor Type, 11.34 kg in each 4.2 gallon blue HDP…
- Reason
- Metal material in raw ingredient used during production of liquid flavor product
- Published
- December 11, 2019
- Distribution
- California, Georgia, Illinois, and Michi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frog Hollow Farm
- Product
- Frog Hollow Holiday Fruitcake Incorrect ingredients: Orga…
- Reason
- Customer alerted firm that walnuts were listed on the web page but not in the ingredient label
- Published
- December 11, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Honey Heaven Wholesale Inc
- Product
- Hummingbird Wholesale Organic Chia Seeds, SD120-5#, packaged…
- Reason
- Seven inch by three quarter inch metal bar was found in a 25# bag of Organic Chia seed when product was being repacked into 5# bags. Metal bar had a jagged edge, with a metal flake loosely attached. There is a possibility that there may have been additional metal flakes that would not be easily seen by consumers.
- Published
- December 11, 2019
- Distribution
- distributed in CA and OR.
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087.
by Avantor Performance Materials Inc
- Reason
- Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.
by AuroMedics Pharma LLC
- Reason
- Presence of Foreign Substance: Foreign material found inside the vial.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
by Preferred Pharmaceuticals, Inc
- Reason
- Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Published
- December 4, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
by AuroMedics Pharma LLC
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
by AuroMedics Pharma LLC
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
by AuroMedics Pharma LLC
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
by AuroMedics Pharma LLC
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Published
- December 4, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
by AuroMedics Pharma LLC
- Reason
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Published
- December 4, 2019
- 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.
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