FDA Recall
Terminated
Historical recordClass II
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
by Calvin Scott & Company, Inc.
- Reason
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37
by Lannett Company, Inc.
- Reason
- Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
by Sanofi-Aventis U.S. LLC
- Reason
- Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
by Ferring Pharmaceuticals Inc
- Reason
- Superpotent Drug
- Published
- August 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0
by Itech 361 LLC
- Reason
- Chemical Contamination: Product contains undeclared methanol.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
by Eosera, Inc.
- Reason
- cGMP Deviations.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
by Golden State Medical Supply Inc.
- Reason
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
by SCA Pharmaceuticals
- Reason
- Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Subpotent drug: Out of specification for assay at the 15-month test interval.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hostess Brands, LLC
- Product
- Hostess Raspberry Zingers, Raspberry Iced Cake With Creamy F…
- Reason
- Product potentially has mold prior to best by date.
- Published
- August 19, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Upspring,ltd
- Product
- UpSpring Baby Iron + Immunity MULTI + IRON + ZINC Promotes n…
- Reason
- May contain undeclared milk
- Published
- August 19, 2020
- 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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