FDA Recall
Terminated
Historical recordClass II
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.
by Ideaz Llc
- Reason
- CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
by Exela Pharma Sciences LLC
- Reason
- Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
by AMA Wholesale
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
by Ideaz Llc
- Reason
- CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grand Canyon Foods International LLC.
- Product
- Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods…
- Reason
- An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
- Published
- May 30, 2018
- Distribution
- Product distributed to retail stores in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grand Canyon Foods International LLC.
- Product
- Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoe…
- Reason
- An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
- Published
- May 30, 2018
- Distribution
- Product distributed to retail stores in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Flowers Bakery Of Montgomery LLC
- Product
- French Toast Bread
- Reason
- Undeclared allergens: Product was mislabeled due to undeclared Milk and Soy
- Published
- May 30, 2018
- Distribution
- FL, IL, MO, TX US Foods - Salem )502…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Flowers Bakery Of Montgomery LLC
- Product
- Hot Dog Buns
- Reason
- Undeclared allergens: Product was mislabeled due to undeclared Milk and Soy
- Published
- May 30, 2018
- Distribution
- FL, IL, MO, TX US Foods - Salem )502…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nature's Only Choice
- Product
- Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALI…
- Reason
- The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
by Apotex Inc.
- Reason
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
by Apotex Inc.
- Reason
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
by Sun Pharmaceutical Industries, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
by Perrigo New York
- Reason
- Failed Stability Specifications
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010
by L. Perrigo Company
- Reason
- Defective delivery system
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
by Pharmalucence, Inc.
- Reason
- Failed Stability Specifications
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
by Boiron Inc.
- Reason
- Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
- Published
- May 23, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
- Published
- May 23, 2018
- 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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