FDA Recall
Terminated
Historical recordClass I
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
by Ultra Supplement LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
by Distributor RFR, LLC.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Tube split from side seam
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications: below specification limits for dissolution.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications: below specification limits for dissolution.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bott…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Nighttime 4oz plastic bo…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Daytime 4oz plastic bott…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Daytime/Nighttime Combo P…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shopaax.com
- Product
- Kingdom Honey Royal Honey VIP The Ultimate Power Source; 12…
- Reason
- Undeclared Sildenafil
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
by Pfizer Inc.
- Reason
- Presence of particulate matter: particulate identified as a beetle.
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications.
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
by MYLAN PHARMACEUTICALS INC
- Reason
- Labeling: Missing label: Label missing from some prefilled pens.
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
by Teva Pharmaceuticals USA Inc
- Reason
- Superpotent Drug: Out of specification assay result was obtained during stability testing.
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
by Dr. Reddy's Laboratories, Inc.
- Reason
- FAILED DISSOLUTION SPECIFICATIONS
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
by Dr. Reddy's Laboratories, Inc.
- Reason
- FAILED DISSOLUTION SPECIFICATIONS
- Published
- August 3, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
by Loud Muscle Science
- Reason
- Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
- Published
- July 27, 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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