FDA Drug Recalls

1,122 recalls, newest first

Class III · Low risk Terminated Jan 20, 2023

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…

Reason Subpotent Drug: Low assay result observed during long-term stability testing.

Lupin Pharmaceuticals Inc. NDC 68180-956-03 D-0174-2023

Class II · Moderate risk Terminated Jan 17, 2023

Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.

Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Urban Electric Power D-0264-2023

Class II · Moderate risk Terminated Jan 17, 2023

Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML)…

Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Urban Electric Power D-0263-2023

Class II · Moderate risk Ongoing Jan 17, 2023

Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen…

Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…

Fisher Scientific Co., LLC D-0164-2023

Class II · Moderate risk Ongoing Jan 17, 2023

Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo…

Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…

Fisher Scientific Co., LLC D-0163-2023

Class II · Moderate risk Terminated Jan 16, 2023

Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED…

Reason Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack…

Preferred Pharmaceuticals, Inc. D-0173-2023

Class II · Moderate risk Terminated Jan 13, 2023

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical…

Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Sun Pharmaceutical Industries INC NDC 47335-679-81 D-0262-2023

Class II · Moderate risk Terminated Jan 13, 2023

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch…

Reason Short Fill

Nephron Sc Inc NDC 0487-5901-99 D-0176-2023

Class II · Moderate risk Terminated Jan 13, 2023

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil…

Reason Short Fill

Nephron Sc Inc NDC 0487-2784-01 D-0175-2023

Class III · Low risk Terminated Jan 13, 2023

FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC…

Reason Short Fill: Underfilled units.

OurPharma LLC NDC 73013-1001-01 D-0172-2023

Class II · Moderate risk Terminated Jan 12, 2023

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per…

Reason CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc NDC 0487-6105-01 D-0178-2023

Class II · Moderate risk Terminated Jan 12, 2023

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th…

Reason CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc D-0177-2023

Class II · Moderate risk Terminated Jan 12, 2023

Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Accord Healthcare, Inc. NDC 16729-134-01 D-0168-2023

Class II · Moderate risk Terminated Jan 11, 2023

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count…

Reason Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were…

Amerisource Health Services LLC NDC 68001-501-00 D-0269-2023

Class II · Moderate risk Ongoing Jan 10, 2023

Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Consolidated Chemical, Inc D-0326-2023

Class II · Moderate risk Ongoing Jan 10, 2023

Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis…

Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Consolidated Chemical, Inc D-0325-2023

Class II · Moderate risk Terminated Jan 6, 2023

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B…

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-0099-2023

Class II · Moderate risk Terminated Jan 5, 2023

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories…

Reason Failed Dissolution Specification

Ascend Laboratories, LLC NDC 67877-591-05 D-0171-2023

Class II · Moderate risk Terminated Jan 5, 2023

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories…

Reason Failed Dissolution Specification

Ascend Laboratories, LLC NDC 67877-591-01 D-0170-2023

Class II · Moderate risk Terminated Jan 5, 2023

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories…

Reason Failed Dissolution Specification

Ascend Laboratories, LLC NDC 67877-590-01 D-0169-2023

Class III · Low risk Terminated Jan 5, 2023

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540…

Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Macleods Pharma USA, INC NDC 33342-022-08 D-0162-2023

Class III · Low risk Terminated Jan 4, 2023

SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park…

Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9…

Intersect ENT, Inc. NDC 10599-003-01 D-0167-2023