FDA Recall
Terminated
Historical recordClass II
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
by Morton Grove Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP deviations
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
by Macleods Pharma Usa Inc
- Reason
- cGmp Deviations
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
by Tsm Brands LLC
- Reason
- Labeling - product contains undeclared ethyl alcohol
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765
by Tsm Brands LLC
- Reason
- Labeling - product contains undeclared ethyl alcohol
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
by Macleods Pharma Usa Inc
- Reason
- cGMP deviations
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vadilal Industries USA Inc.
- Product
- Vadilal Quick Treat Custard Apple Pulp Net Wt, 1kg/35.27-oz…
- Reason
- Product may be contaminated with Salmonella
- Published
- March 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3; Premium Nature, South Plainfield, NJ.
by AMS Packaging Inc
- Reason
- Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
by AMS Packaging Inc
- Reason
- Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
by Positive Health
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1
by Perrigo Company PLC
- Reason
- CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- Published
- March 2, 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.
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