Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,055 recalls · Class II, newest first

Class II · Moderate risk

Acetylcysteine 10%

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0054-2015
Class II · Moderate risk

Propranolol Hydrochloride Injection

CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.

Terminated cGMP deviation Fresenius Kabi USA, LLC NDC 63323-604-01 D-1545-2014
Class II · Moderate risk

Rector's Remedy OINTMENT

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing and lack of OTC drug labeling requirements.

Terminated Unapproved drug New Gpc Inc. D0035-2015
Class II · Moderate risk

Whitfield's OINTMENT B.P.

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A.

Terminated Unapproved drug New Gpc Inc. D0034-2015
Class II · Moderate risk

Whitfield Lotion

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Terminated Unapproved drug New Gpc Inc. D0033-2015
Class II · Moderate risk

Ferrol EXPECTORANT

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Terminated Unapproved drug New Gpc Inc. D0032-2015
Class II · Moderate risk

Mustarcreme

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Terminated Unapproved drug New Gpc Inc. D0031-2015
Class II · Moderate risk

alcosulph Astringent Lotion

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Terminated Unapproved drug New Gpc Inc. D0030-2015
Class II · Moderate risk

alcosulph Moisturizing Cream

Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..

Terminated Unapproved drug New Gpc Inc. D0029-2015
Class II · Moderate risk

Children's Q-Pap

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Terminated Wrong potency / content Qualitest Pharmaceuticals NDC 0603-0843-54 D-0039-2015
Class II · Moderate risk

Children's Q-Pap

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Terminated Wrong potency / content Qualitest Pharmaceuticals NDC 0603-0842-54 D-0038-2015
Class II · Moderate risk

Children's Q-Pap

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Terminated Wrong potency / content Qualitest Pharmaceuticals NDC 0603-0841-54 D-0037-2015
Class II · Moderate risk

ZyGenerics ATENOLOL Tablets

Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Terminated Wrong potency / content Zydus Pharmaceuticals USA Inc NDC 68382-022-01 D-0007-2015
Class II · Moderate risk

ProSol - sulfite-free

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

Terminated Particulate / foreign matter Baxter Healthcare Corp NDC 0338-0499-06 D-1542-2014
Class II · Moderate risk

CYTARAbine for Injection USP

Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Terminated Sterility / contamination Ben Venue Laboratories Inc NDC 55390-808-01 D-1543-2014
Class II · Moderate risk

Alprazolam Tablets

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Terminated Particulate / foreign matter Mckesson Packaging Services NDC 63739-644-10 D-1515-2014
Class II · Moderate risk

Alprazolam Tablets

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Terminated Particulate / foreign matter Sandoz Incorporated NDC 0781-1061-10 D-1509-2014
Class II · Moderate risk

Fagron

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Terminated Microbial contamination Fagron, Inc NDC 51552-1285-8 D-1498-2014
Class II · Moderate risk

Fagron

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Terminated Microbial contamination Fagron, Inc NDC 51552-0919-8 D-1497-2014

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