Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
FDA Drug Recalls
554 recalls · Class I, newest first
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Naloxone Hydrochloride Injection
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class I · High risk
Allergan Taytulla Softgel Capsules
Contraceptive Tablets Out of Sequence.
Class I · High risk
7K capsules packaged in single packs sold in 24-count boxes
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
POSEIDON Xtreme PLATINUM 4500
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Piperacillin and Tazobactam for Injection
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I · High risk
Piperacillin and Tazobactam for Injection
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I · High risk
Piperacillin and Tazobactam for Injection
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I · High risk
Ampicillin and Sulbactam for Injection
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Class I · High risk
Euphoric Premium Male Performance Enhancer capsules
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Class I · High risk
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack
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.
Class I · High risk
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Class I · High risk
Red Zone Xtreme 3000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class I · High risk
Bella Capsules
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Limbrel500
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel250
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 500 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 250 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Senna Laxative
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Class I · High risk
Hcg 5
Non-Sterility