Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
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FDA Drug Recalls

14,806 recalls, newest first

Class II · Moderate risk

Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper

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-0059-2015
Class II · Moderate risk

Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper

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-0058-2015
Class II · Moderate risk

Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial

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-0057-2015
Class II · Moderate risk

Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper

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-0056-2015
Class II · Moderate risk

Acetylcysteine 20%

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-0055-2015
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 III · Low risk

Nicotine Polacrilex Lozenge

Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Terminated Dissolution failure Perrigo Holland Inc D-1558-2014
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-010-90 D-0246-2015
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 I · High risk

CUBICIN (daptomycin for injection)

Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

Terminated Particulate / foreign matter Cubist Pharmaceuticals, Inc. NDC 67919-011-01 D-0229-2015
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 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

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