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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

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Drug Recall Terminated Historical recordClass II

Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Drug Recall Terminated Historical recordClass II

FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

by Specialty Medicine Compounding Pharmacy

Reason: Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Recall initiated: October 19, 2013
Reported by FDA: January 22, 2014
Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.

View recall →

Data last updated: October 2, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.