US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Ongoing

Assured Instant Hand Sanitizer Vitamin E and Aloe

Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Albek De Mexico S.A. De C.V. D-0081-2021
Class II · Moderate risk Ongoing

Assured Instant Hand Sanitizer Aloe & Moisturizers

Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Albek De Mexico S.A. De C.V. D-0080-2021
Class II · Moderate risk Ongoing

Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera

Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Albek De Mexico S.A. De C.V. D-0079-2021
Class II · Moderate risk Ongoing

NuuxSan Instant ANTIBACTERIAL HAND SANITIZER

Reason CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Albek De Mexico S.A. De C.V. D-0078-2021
Class I · High risk Terminated

Heparin Sodium 10

Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

SCA Pharmaceuticals D-1553-2020
Class I · High risk Terminated

Heparin Sodium 5

Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

SCA Pharmaceuticals D-1552-2020
Class I · High risk Terminated

Heparin Sodium 5

Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

SCA Pharmaceuticals D-1551-2020
Class I · High risk Terminated

Heparin Sodium 2

Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

SCA Pharmaceuticals D-1550-2020
Class II · Moderate risk Terminated

Heparin Sodium 5

Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

SCA Pharmaceuticals NDC 70004-0650-46 D-1495-2020
Class I · High risk Terminated

Herbacil

Reason Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.

Broncolin, S.A. de C.V. D-1578-2020
Class II · Moderate risk Terminated

Herbacil

Reason CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Broncolin, S.A. de C.V. D-1577-2020
Class II · Moderate risk Terminated

Phentermine HCL Blue Speckled tablets

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 10702-0025-10 D-1532-2020
Class II · Moderate risk Terminated

Phentermine HCL White/Blue Speckled tablets

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 00527-1445-10 D-1531-2020
Class II · Moderate risk Terminated

Phentermine HCL White/Blue Speck Tabs 37.5 mg

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 53489-0676-10 D-1530-2020
Class II · Moderate risk Terminated

Phentermine HCL Blue/White Capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 10702-0029-10 D-1529-2020
Class II · Moderate risk Terminated

Phentermine HCL Blue/Clear capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 10702-0028-10 D-1528-2020
Class II · Moderate risk Terminated

Phentermine HCL Yellow Caps 30mg

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 51224-0202-70 D-1527-2020
Class II · Moderate risk Terminated

Phentermine HCL GrayYellow capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 51224-0203-70 D-1526-2020
Class II · Moderate risk Terminated

Phentermine 15mg grey/Yellow Capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 11534-0157-03 D-1525-2020
Class II · Moderate risk Terminated

Phentermine HCL Gray/Yellow capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 10702-0026-10 D-1524-2020
Class II · Moderate risk Terminated

Phendimetrazine Brown/Clear Capsules

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 69543-0409-11 D-1523-2020
Class II · Moderate risk Terminated

Phendimetrazine Yellow Tabs 35mg

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 69543-0410-11 D-1522-2020
Class II · Moderate risk Terminated

Phendimetrazine Yellow Tabs 35mg

Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Calvin Scott & Company, Inc. NDC 0702-0077-10 D-1521-2020