FDA Recall
Ongoing
Historical recordClass II
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
by Mayne Pharma Inc
- Reason
- CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
by Lohxa, LLC
- Reason
- Microbial Contamination of Non-Sterile Product
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
by Ingenus Pharmaceuticals Llc
- Reason
- CGMP Deviations
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ
by Teva Pharmaceuticals USA
- Reason
- Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
- Published
- January 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Mango Pickle (Fresh Avakai) packaged in white plastic pouch,…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Ginger Pickle (Fresh Allam Avakai) was packaged in white pla…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Jackfruit Mango Pickle (Fresh Panasapottu) was packaged in w…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Mango Ginger Pickle (Fresh Mamidi Allam) was packaged in whi…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Curry Leaf Hot Pickle packaged in white plastic pouch, net w…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Fresh Banana Pickle is packaged in clear plastic pouch, net…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aroma Meats LLC
- Product
- Daliya Split Powder (Putnala Podi), packaged in white plasti…
- Reason
- Product was from unapproved source.
- Published
- January 26, 2022
- Distribution
- Distributed in Oregon.
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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