US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

HAND SANITIZER Isopropyl Alcohol Antiseptic 75%

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Tennessee Technical Coatings, Corp. NDC 76921-000-01 D-0740-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Golden State Medical Supply Inc. NDC 60429-504-18 D-0654-2022
Class II · Moderate risk Terminated

HEB 50% Isopropyl Alcohol First Aid Antiseptic

Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.

Vi-Jon, Inc. D-0644-2022
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection USP

Reason Lack of sterility assurance: leaking bags

B. Braun Medical, Inc. NDC 0264-7800-20 D-0655-2022
Class II · Moderate risk Terminated

hydrALAZINE HCl Tablets

Reason Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.

The Harvard Drug Group NDC 0904-6440-61 D-0653-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason CGMP deviations

Preferred Pharmaceuticals, Inc. D-0642-2022
Class II · Moderate risk Terminated

Dexamethasone Elixir

Reason Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Morton Grove Pharmaceuticals, Inc. NDC 60432-466-08 D-0713-2022
Class II · Moderate risk Ongoing

All Over-The-Counter

Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

Dollar Tree Distribution, Inc. D-0641-2022
Class II · Moderate risk Terminated

Olanzapine Tablets

Reason cGmp Deviations

Macleods Pharma Usa Inc NDC 33342-070-07 D-0639-2022
Class II · Moderate risk Terminated

Pyrazinamide Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-660-10 D-0568-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-903-10 D-0567-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-902-10 D-0566-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-901-10 D-0565-2022
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason cGMP Deviations

ANI Pharmaceuticals, Inc. NDC 67253-900-10 D-0564-2022
Class II · Moderate risk Terminated

Diazepam Oral Solution

Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Lannett Company, Inc. NDC 0527-1768-36 D-0558-2022
Class II · Moderate risk Terminated

Erythromycin Topical Gel USP

Reason Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.

Teligent Pharma, Inc. NDC 63739-053-66 D-0716-2022
Class II · Moderate risk Ongoing

Luxury 70% Isopropyl Alcohol

Reason Labeling - product contains undeclared ethyl alcohol

Tsm Brands LLC D-0636-2022
Class II · Moderate risk Terminated

Chlorthalidone Tablets USP 25 mg

Reason Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Sun Pharmaceutical Industries INC NDC 57664-648-88 D-0578-2022
Class II · Moderate risk Ongoing

Methylphenidate Hydrochloride Chewable Tablets

Reason Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

Rising Pharmaceuticals NDC 64980-221-01 D-0573-2022
Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-4077-1 D-0572-2022