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

1,273 recalls, newest first

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 I · High risk

Dianeal Low Calcium

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0941-0457-05 D-1610-2014
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 III · Low risk

Rifampin for Injection USP

Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

Terminated Impurity / degradation Akorn, Inc. NDC 17478-151-42 D-1571-2014
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 III · Low risk

Depo-Medrol

Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0

Terminated Failed specification Pfizer Inc. NDC 0009-3073-03 D-1537-2014
Class III · Low risk

Cataflam (diclofenac potassium)

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Terminated Failed specification Novartis Pharmaceuticals Corp. NDC 0078-0436-05 D-1516-2014
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 I · High risk

Lidocaine HCl Injection

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-2066-05 D-0020-2015
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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