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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Olympia Pharmacy Sterile Compounded Drugs Recalled for Manufacturing Issues

Agency Publication Date: April 27, 2022
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Summary

Olympia Compounding Pharmacy (dba Olympia Pharmacy) is recalling 146,147 vials of various sterile compounded drugs and diluents distributed nationwide. This voluntary recall was initiated due to manufacturing quality issues, specifically failure to investigate environmental and personnel monitoring excursions and, in one instance, a powder that failed to dissolve properly within the required timeframe. The affected products include a wide range of injectable medications such as Testosterone, Sermorelin, NAD+, and several specialty compounded formulations.

Risk

Manufacturing deviations in sterile compounding environments can lead to a risk of product contamination. If a drug is not properly sterile or does not dissolve (reconstitute) correctly, it may cause infection or fail to deliver the intended dose to the patient. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects various sterile compounded medications sold under the Olympia Pharmaceuticals brand, including Testosterone Cypionate, Sermorelin Acetate, NAD+, B12 (Hydroxocobalamin), and various specialty formulas labeled as QM, T, SB, RE, and AT series.
  2. Check your medication vial labels for the brand 'Olympia Pharmaceuticals' and specific lot numbers or NDC codes printed on the packaging.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange for the return of any remaining inventory.
  5. If you have health concerns regarding the use of these medications, contact your healthcare provider or pharmacist.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Diluent for Reconstitution (10 mL)
Variants: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, Multi-Dose vial
Lot Numbers:
D41012 (BUD 4/12/2022)
D41212 (BUD: 4/12/2022)
D47026 (BUD: 4/26/2022)
E41017 (BUD: 5/17/2022)
E41018 (BUD: 5/18/2022)
E47004 (BUD: 5/4/2022)
E47024 (BUD: 5/24/2022)
E47026 (BUD: 5/26/2022)
E48005 (BUD: 5/5/2022)
G47014 (BUD: 7/14/2022)
H48816 (BUD: 8/16/2022)
NDC:
73198-0113-10

Recall #: D-0796-2022

Product: Sermorelin Acetate, Lyophilized powder for reconstitution
Variants: 3 mg per vial, 9 mg per vial, Multi-Dose vials
Lot Numbers:
D41019 (BUD: 4/19/2022)
D41112 (BUD: 4/12/2022)
D47028 (BUD: 4/28/2022)
F24009 (BUD 3/4/2022)
F41001 (BUD: 6/1/2022)
G48006 (BUD: 7/14/2022)
G48008 (BUD: 7/8/2022)
G48012 (BUD: 7/12/2022)
G48014 (BUD: 7/14/2022)
G48019 (BUD: 7/9/2022)
I24009 (BUD: 9/9/2022)
I41107 (BUD: 9/7/2022)
NDC:
73198-0060-00
73198-0059-00

Recall #: D-0797-2022

Product: QM-2 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 60 mcg/mL, Atropine 0.2 mg/mL, Multi-Dose vial
Lot Numbers:
D41219 (BUD: 4/19/2022)
I24C13 (BUD: 9/13/2022)
NDC:
73198-0018-10

Recall #: D-0798-2022

Product: T-50 Formula (10 mL)
Variants: Papaverine 8 mg/mL, Phentolamine 0.29 mg/mL, Alprostadil 2.9 mcg/mL, Multi-Dose vial
Lot Numbers:
G24F01 (BUD: 7/1/2022)
G41316 (BUD: 7/16/2022)
H24B03 (BUD: 8/3/2022)
H24C03 (BUD: 8/3/2022)
NDC:
73198-0022-10

Recall #: D-0820-2022

Product: Formula F2 (10 mL)
Variants: Papaverine 9 mg/mL, Phentolamine 1 mg/mL, Alprostadil 10 mcg/mL, Atropine 0.1 mg/mL, Multi-Dose vial
Lot Numbers:
G48C20 (BUD: 7/20/2022)
G48B20 (BUD: 7/22/2022)
NDC:
73198-0002-10

Recall #: D-0821-2022

Product: Phenylephrine 1 mg/mL (5 mL)
Variants: Multi-Dose vial
Lot Numbers:
H47030 (BUD: 8/30/2022)
NDC:
73198-0021-05

Recall #: D-0822-2022

Product: NAD+ Nicotinamide Adenine Dinucleotide (500 mg)
Variants: Lyophilized powder for reconstitution, Multi-Dose vial
Lot Numbers:
E24026 (BUD: 5/26/2022)
E42112 (BUD: 5/12/2022)
E48024 (BUD: 2/2/2022)
F24014 (BUD: 6/14/2022)
G48028 (BUD: 7/28/2022)
H24016 (BUD: 8/16/2022)
H42010 (BUD 8/10/2022)
H48030 (BUD: 8/11/2022)
I47003 (BUD: 8/11/2022)
F41116 (BUD: 6/16/2022)
NDC:
73198-0083-00

Recall #: D-0795-2022 and D-0828-2022. Lot F41116 recalled for failed reconstitution time.

Product: PGE-2, Alprostadil 80 mcg/mL (10 mL)
Variants: Multi-Dose vial
Lot Numbers:
F48102 (BUD: 6/2/2022)
NDC:
73198-0029-10

Recall #: D-0818-2022

Product: PGE-3, Alprostadil 150 mcg/mL (10 mL)
Variants: Multi-Dose vial
Lot Numbers:
G24C19 (BUD: 7/19/2022)
NDC:
73198-0030-10

Recall #: D-0819-2022

Product: T-105 Formula
Variants: Papaverine 30mg/mL, Phentolamine 1mg/ml, PGE 10mcg/ml, 10 ml Multi-Dose vial, 5 ml Multi-Dose vial, 2.5 ml Multi-Dose vial
Lot Numbers:
D41412 (BUD: 4/22/2022)
E41F10 (BUD: 5/10/2022)
E41G10 (BUD: 5/10/2022)
F24D21 (BUD: 6/21/2022)
D41512 (BUD: 4/12/2022)
F42B21 (BUD: 6/21/2022)
H42B03 (BUD: 8/3/2022)
H42C03 (BUD: 8/3/2022)
NDC:
73198-0005-10
73198-0005-05
73198-0005-03

Recall #: D-0799-2022

Product: Formula F9 (10 mL)
Variants: Papaverine 0.9mg/ml, Phentolamine 0.1mg/ml, PGE 20mcg/mL, Atropine 0.01mg/ml, Multi-Dose vial
Lot Numbers:
D41C19 (BUD: 4/19/2022)
I42C13 (BUD: 9/13/2022)
I42B13 (BUD: 9/13/2022)
NDC:
73198-0004-10

Recall #: D-0800-2022

Product: AT-6 Formula (10 mL)
Variants: Papaverine 40mg/ml, Phentolamine 4mg/ml, Atropine 0.3mg/ml, Multi-Dose vial
Lot Numbers:
D41E20 (BUD: 4/20/2022)
D41F20 (BUD: 4/20/2022)
G41C13 (BUD: 7/13/2022)
G41B13 (BUD: 7/13/2022)
NDC:
73198-0040-10

Recall #: D-0801-2022

Product: AT-1 Formula (10 mL)
Variants: Papaverine 8mg/ml, Phentolamine 2mg/ml, Atropine 0.2mg/ml, Multi-Dose vial
Lot Numbers:
F41C28 (BUD: 6/28/2022)
F41B28 (BUD: 6/28/2022)
NDC:
73198-0039-10

Recall #: D-0802-2022

Product: NB-243 Formula (10 mL)
Variants: Papaverine 30mg/ml, Phentolamine 3mg/ml, Alprostadil 20mcg/ml, Multi-Dose vial
Lot Numbers:
I24C28 (BUD: 9/28/2022)
D41I19 (BUD: 4/19/2022)
F41321 (BUD: 6/21/2022)
I24128 (BUD: 9/28/2022)
NDC:
73198-0009-10

Recall #: D-0803-2022

Product: T-106 Formula
Variants: Papaverine 30 mg/mL, Phentolamine 1 mg/mL, Alprostadil 25 mcg/mL, 10 mL Multi-Dose vial, 5 mL Multi-Dose vial
Lot Numbers:
E24510 (BUD: 5/10/2022)
E24610 (BUD: 5/10/2022)
H42H03 (BUD: 8/3/2022)
E24810 (BUD: 5/10/2022)
H42203 (BUD: 8/3/2022)
NDC:
73198-0013-10
73198-0013-05

Recall #: D-0804-2022

Product: T-101 Formula
Variants: Papaverine 17.65 mg/mL, Phentolamine 0.59 mg/mL, Alprostadil 5.9 mcg/mL, 10 mL Multi-Dose vial, 5 mL Multi-Dose vial
Lot Numbers:
E41B10 (BUD: 5/10/2022)
E41B08 (BUD: 5/10/2022)
I41C08 (BUD: 9/8/2022)
I41D08 (BUD: 9/8/2022)
E41C10 (BUD: 5/10/2022)
NDC:
73198-0014-10
73198-0014-05

Recall #: D-0805-2022

Product: SB-4 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 40 mcg/mL, Multi-Dose vial
Lot Numbers:
E41C18 (BUD: 5/18/2022)
E41D18 (BUD: 5/18/2022)
G42D20 (BUD: 7/20/2022)
G42B20 (BUD: 7/20/2022)
NDC:
73198-0023-10

Recall #: D-0806-2022

Product: SB-5 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, PGE 50 mcg/mL, Multi-Dose vial
Lot Numbers:
E48B18 (BUD: 5/18/2022)
E48D18 (BUD; 5/18/2022)
H24D31 (BUD: 8/31/2022)
E48C18 (BUD: 5/18/2022)
NDC:
73198-0024-10

Recall #: D-0807-2022

Product: SB-6 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, PGE 60 mcg/mL, Multi-Dose vial
Lot Numbers:
E41H18 (BUD: 5/18/2022)
G41319 (BUD: 7/19/2022)
NDC:
73198-0025-10

Recall #: D-0808-2022

Product: ST-1 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 1.5 mg/mL, Alprostadil 50 mcg/ml, Multi-Dose vial
Lot Numbers:
H24F03 (BUD: 8/3/2022)
H24E03 (BUD: 8/3/2022)
NDC:
73198-0011-10

Recall #: D-0809-2022

Product: ST-2 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 100 mcg/mL, Multi-Dose vial
Lot Numbers:
F41C21 (BUD: 6/21/2022)
G42013 (BUD: 7/13/2022)
H41C31 (BUD: 8/31/2022)
F41D21 (BUD: 6/21/2022)
NDC:
73198-0012-10

Recall #: D-0810-2022

Product: QM-3 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 150 mcg/mL, Atropine 0.2 mg/mL, Multi-Dose vial
Lot Numbers:
E42B12 (BUD: 5/12/2022)
E42C12 (BUD: 5/12/2022)
E42D12 (BUD: 5/12/2022)
H24B23 (BUD: 8/23/2022)
H24C23 (BUD: 8/23/2022)
H24D23 (BUD: 8/23/2022)
NDC:
73198-0019-10

Recall #: D-0811-2022

Product: QM-4 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 300 mcg/mL, Atropine 0.2 mg/mL, Multi-Dose vial
Lot Numbers:
E41027 (BUD: 5/27/2022)
I24E13 (BUD: 9/13/2022)
NDC:
73198-0020-10

Recall #: D-0812-2022

Product: RE-1 Formula
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 200 mcg/mL, 10 mL Multi-Dose vial, 2.5 mL Multi-Dose vial
Lot Numbers:
E47B18 (BUD: 5/18/2022)
E47C18 (BUD: 5/18/2022)
H24G31 (BUD: 8/31/2022)
NDC:
73198-0015-10
73198-0015-03

Recall #: D-0813-2022

Product: RE-2 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 300 mcg/mL, Multi-Dose vial
Lot Numbers:
E42G11 (BUD: 5/11/2022)
H41003 (BUD: 8/3/2022)
H41B03 (BUD: 8/3/2022)
NDC:
73198-0016-10

Recall #: D-0814-2022

Product: BIMIX-3 Formula (10 mL)
Variants: Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Multi-Dose vial
Lot Numbers:
F24C10 (BUD: 6/10/2022)
NDC:
73198-0027-10

Recall #: D-0815-2022

Product: FA Formula (10 mL)
Variants: Papaverine 20 mg/mL, Phentolamine 2 mg/mL, Alprostadil 20 mcg/mL, Atropine 0.2 mg/mL, Multi-Dose vial
Lot Numbers:
F41414 (BUD: 6/14/2022)
F41C14 (BUD: 6/14/2022)
I24E28 (BUD: 9/28/2022)
I24F28 (BUD: 9/28/2022)
NDC:
73198-0006-10

Recall #: D-0816-2022

Product: PGE-1, Alprostadil 40 mcg/mL (10 mL)
Variants: Multi-Dose vial
Lot Numbers:
I24028 (BUD: 9/28/2022)
F47C30 (BUD: 6/30/2022)
F47B30 (BUD: 6/30/2022)
NDC:
73198-0028-10

Recall #: D-0817-2022

Product: Testosterone Cypionate 200 mg/mL (in Grapeseed Oil)
Variants: 10 mL Multi-Dose vial, 5 mL Multi-Dose vial
Lot Numbers:
D48027 (BUD: 4/27/2022)
E47017 (BUD: 5/17/2022)
F42007 (BUD: 6/7/2022)
F42107 (BUD: 6/7/2022)
F42207 (BUD: 6/7/2022)
F48009 (BUD: 6/9/2022)
F48109 (BUD: 6/9/2022)
H47003 (BUD: 8/3/2022)
F24024 (BUD: 6/24/2022)
NDC:
73198-0054-10
73198-0054-05

Recall #: D-0823-2022

Product: Testosterone Cypionate 200 mg/mL (in Sesame Oil)
Variants: 10 mL Multi-Dose vial, 5 mL Multi-Dose vial
Lot Numbers:
E48019 (BUD: 5/19/2022)
F42109 (BUD: 6/9/2022)
F42C09 (BUD: 6/9/2022)
G47012 (BUD: 7/12/2022)
G47112 (BUD: 7/12/2022)
F42B09 (BUD: 6/9/2022)
NDC:
73198-0055-10
73198-0055-05

Recall #: D-0824-2022

Product: Ultratest (10 mL)
Variants: Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, Multi-Dose vial
Lot Numbers:
E48020 (BUD: 5/20/2022)
G47006 (BUD: 7/6/2022)
NDC:
73198-0058-10

Recall #: D-0825-2022

Product: Hydroxocobalamin B12, 1 mg/mL (30 mL)
Variants: Multi-Dose vial
Lot Numbers:
D48026 (BUD: 4/26/2022)
E48025 (BUD: 5/25/2022)
G48B21 (BUD: 7/21/2022)
G48C21 (BUD: 7/21/2022)
NDC:
73198-0080-30

Recall #: D-0826-2022

Product: Sincalide (5 mcg)
Variants: Lyophilized powder for reconstitution, Multi-Dose vial
Lot Numbers:
F24018 (BUD: 6/18/2022)
G47021 (BUD: 7/21/2022)
NDC:
73198-0082-00

Recall #: D-0827-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89938
Status: Resolved
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Sold By: Olympia Pharmaceuticals; Physician Clinics
Manufactured In: United States
Units Affected: 33 products (16,329 vials; 45,935 vials; 18060 vials; 1871 vials; 6916 vials; 800 vials; 1318 vials; 310 vials; 3509 vials; 4129 vials; 2437 vials; 1740 vials; 1110 vials; 336 vials; 525 vials; 2005 vials; 1679 vials; 1647 vials; 1849 vials; 2201 vials; 388 vials; 2887 vials; 821 vials; 460 vials; 410 vials; 1097 vials; 257 vials; 4521 vials; 7161 vials; 3962 vials; 1276 vials; 6431 vials; 1770 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.