FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
by Amerisource Health Services
- Reason
- Presence of Foreign Tablets/Capsules.
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
by Leading Pharma, LLC
- Reason
- Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
by Fagron, Inc
- Reason
- cGMP Deviations: lack of quality assurance at the API manufacturer.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
by Genzyme Corporation
- Reason
- Labeling: Incorrect or Missing Package Insert.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
by Amerisource Health Services
- Reason
- Failed Stability Specifications
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
doTERRA International, LLC
- Product
- Slim & Sassy¿ TrimShake Chocolate, SKU 35200001, 1 lb 5.9…
- Reason
- doTERRA is voluntarily recalling unexpired Slim & Sassy¿ TrimShake - Chocolate and Slim & Sassy¿ TrimShake Vanilla mixes due to an undeclared milk allergen.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
doTERRA International, LLC
- Product
- Slim & Sassy¿ TrimShake Vanilla, SKU 35180001, 1 lb 5.9 oz,…
- Reason
- doTERRA is voluntarily recalling unexpired Slim & Sassy¿ TrimShake - Chocolate and Slim & Sassy¿ TrimShake Vanilla mixes due to an undeclared milk allergen.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Turbinado Almonds w/ Sea Salt packaged in :…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Coffee beans packaged in Bulk 4 oz. Plasti…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Pl…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Aurora Brand Dark Chocolate Cherries packaged in: 8.5 oz.…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Almonds packaged in: 4 oz. Plastic Pouch,…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
by Dr. Reddy's Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
- Published
- November 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
by Purdue Pharma, LP
- Reason
- Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
- Published
- November 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
- Published
- November 8, 2017
- 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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