FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
by Teva Pharmaceuticals USA
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
by Teva Pharmaceuticals USA
- Reason
- Failed Stability Specifications
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
by Par Sterile Products LLC
- Reason
- Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
by Akorn, Inc.
- Reason
- Product is being recalled due to low pH value.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 32 count Miss Vickies Multipack Box 44 oz. packaged in flexi…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 30 count Lays Kettle Cooked Multipack Tray 41.25 oz. package…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 30 count Miss Vickies Multipack Tray 41.25 oz. packaged in f…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexib…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 12 count Lays Kettle Cooked Multipack Sack 10.2 oz packaged…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- Jalape¿o Flavored Lays Kettle Cooked potato chips and Jalape…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Treehouse Foods
- Product
- Macaroni & Cheese microwaveable cups sold under the followin…
- Reason
- Products containing cheddar cheese seasoning which may be contaminated with Salmonella.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Great Value Bread and Butter Chips 24 Fl Oz. Distributed b…
- Reason
- Glass fragments were found in Great Value Bread and Butter Chips.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jimmy's Cookies
- Product
- The Bakery Peanut Butter Chocolate Chunk Cookies, Net Wt. 14…
- Reason
- The Bakery Peanut Butter Chocolate Chunk Cookies may contain undeclared milk.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
by Akorn Inc
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
by Fagron, Inc
- Reason
- Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
by P & L Development, LLC
- Reason
- Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
- Published
- May 10, 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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