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

1,070 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2015 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

SIU-Papav/Phentol 30/1 mg/mL Injection

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Terminated Sterility / contamination The Apothecary Shoppe LLC NDC 99999-6830-10 D-1296-2015
Class II · Moderate risk

SIU-Papav/Phent 24/1 mg/mL Inj.

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

Terminated Sterility / contamination The Apothecary Shoppe LLC NDC 13861-1461-57 D-1295-2015
Class II · Moderate risk

SIU-Papaverine 30 mg/mL Inj.

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Terminated Sterility / contamination The Apothecary Shoppe LLC NDC 99999-1775-10 D-1294-2015
Class II · Moderate risk

S-methylcobalamin 25 mg/mL

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Terminated Sterility / contamination The Apothecary Shoppe LLC NDC 13861-1701-19 D-1292-2015
Class II · Moderate risk

S-Methylcobalamin 1000 mcg/mL

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Terminated Sterility / contamination The Apothecary Shoppe LLC NDC 14294-1962-40 D-1289-2015
Class II · Moderate risk

Methylcobalamin 1

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1404-2015
Class II · Moderate risk

Hydroxocobalamin

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1402-2015
Class II · Moderate risk

Doxycycline/0.9% NaCl 300 mg/500 mL IV

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1401-2015
Class II · Moderate risk

Methadone 10 mg/mL Injection

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1399-2015
Class II · Moderate risk

Phenol 6% Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1398-2015
Class II · Moderate risk

Glycerin (v/v)

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1397-2015
Class II · Moderate risk

Morphine/0.9 % NaCl 1 mg/mL IV

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1396-2015
Class II · Moderate risk

Dexamethasone 24 mg/mL Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1395-2015
Class II · Moderate risk

Doxycycline/0.9% NaCl 150 mg/250 mL IV

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1394-2015
Class II · Moderate risk

Papervine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1393-2015
Class II · Moderate risk

Hydroxocobalamin

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1392-2015
Class II · Moderate risk

Doxycycline/0.9 % NaCl 100 mg/100 mL IV

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1390-2015
Class II · Moderate risk

Tobramycin 14 mg/mL Ophthalmic Solution

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1389-2015

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