US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Ear Itch MD Anti-Itch Spray

Reason cGMP Deviations.

Eosera, Inc. NDC 72429-0071-5 D-1500-2020
Class II · Moderate risk Terminated

Nystatin Oral Suspension

Reason Subpotent drug: Out of specification for assay at the 15-month test interval.

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0810-16 D-1494-2020
Class II · Moderate risk Terminated

Leiper's Fork Distillery

Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol.

Leiper's Fork Distillery D-1561-2020
Class II · Moderate risk Terminated

Jaloma Antiseptic Hand Sanitizer

Reason cGMP deviations

Laboratorios Jaloma S.A. de C.V. NDC 65055-600-02 D-1555-2020
Class II · Moderate risk Terminated

Hand Sanitizer

Reason Discoloration and Presence of Foreign Substance

Ecolab Inc NDC 47593-624-21 D-1539-2020
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 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
Class II · Moderate risk Terminated

Topiramate 25mg Tabs White/round tablets

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

Calvin Scott & Company, Inc. NDC 47335-0707-13 D-1520-2020
Class II · Moderate risk Terminated

Thyroid Neutral Tabs 2 gr

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

Calvin Scott & Company, Inc. NDC 64727-3308-02 D-1519-2020