FDA Recall
TerminatedTerminated: March 16, 2015Historical recordClass II
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
by SigmaPharm Laboratories LLC
- Reason
- Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 26, 2016Historical recordClass II
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 9, 2015Historical recordClass II
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System; defective valve
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: February 3, 2015Historical recordClass I
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
by Schindele Enterprises dba Midwest Wholesale
- Reason
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Published
- May 28, 2014
- Distribution
- Distributed to PA, IL, TX, IA, GA, CT, F…
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 10, 2017Historical recordClass I
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
by Pfizer Us Pharmaceutical Group
- Reason
- Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 18, 2014Historical recordClass I
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
by HUMAN SCIENCE FOUNDATION
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 29, 2015Historical recordClass I
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
by Ben Venue Laboratories Inc
- Reason
- Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 20, 2014Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 20, 2014Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- 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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