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Stop using now Drug recall · FDA · Published January 15, 2016

Recall: Abbott's Progesterone/Testosterone Oil Due to Sterility Risks

Abbott's Compounding Pharmacy recalls all unexpired lots of sterile compounded progesterone/testosterone oil due to lack of sterility assurance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0715-2016DrugAbbott's Compounding Pharmacy ›
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Recalling firmAbbott's Compounding Pharmacy, Inc.2320 Woolsey St · Berkeley, CA 94705-1973
✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of its sterile compounded progesterone/testosterone (ss oil) product. The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these medications. Because the product is intended to be sterile, this defect poses a risk of infection to users. Read more at govinfonow.com/recall/43223-recall-abbott-s-progesterone-testosterone-oil-due-to-sterility-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/43223-recall-abbott-s-progesterone-testosterone-oil-due-to-sterility-risks · Updated October 11, 2026 · FDA enforcement record: FDA #D-0715-2016

Cite this page

“Recall: Abbott's Progesterone/Testosterone Oil Due to Sterility Risks.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43223-recall-abbott-s-progesterone-testosterone-oil-due-to-sterility-risks. Based on FDA recall #D-0715-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0715-2016%22&limit=1).

Why it’s dangerous

The primary hazard is a lack of sterility assurance, meaning the medication might contain harmful microorganisms. Using non-sterile injectable products can lead to serious infections or other adverse health events when introduced into the body.

Who’s affected

Patients in California who have been prescribed or purchased this specific compounded medication from Abbott's Compounding Pharmacy are affected. Individuals using these injections are at risk because the product may not be sterile as required for safe administration.

How to tell if you have this one

Look for progesterone/testosterone (ss oil) with a concentration of 0.25/20 mg/mL in 10 mL unit sizes. The product is labeled as 'room temperature' and 'This Rx is Compounded.' It was distributed in California, and all lots are included in this recall.

  • Brand
    Abbott's Compounding Pharmacy
  • Category
    Drug
FDA recall event · 43 products

All 43 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    CA
Recall numberProduct, codes & lotsQuantity
D-0676-2016Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots7200 mL
D-0677-2016calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All Lots200 ml
D-0678-2016Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All Lots5 ml
D-0679-2016Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots30 ml
D-0680-2016Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All Lots6 ml
D-0681-2016Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All Lots90 ml
D-0682-2016hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots38 ml
D-0683-2016hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots20 ml
D-0684-2016Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0685-2016methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All Lots22 ml
D-0686-2016methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots41 ml
D-0687-2016methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots35 ml
D-0688-2016papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0689-2016papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots—
D-0690-2016papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots30 ml
D-0691-2016papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0692-2016papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0693-2016papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0694-2016papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0695-2016papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0696-2016papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0697-2016papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0698-2016papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0699-2016papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0700-2016papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0701-2016papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots25 ml
D-0702-2016papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0703-2016papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0704-2016papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0705-2016papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots62 ml
D-0706-2016papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0707-2016papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots40 ml
D-0708-2016papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0709-2016papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0710-2016papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0711-2016papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots5 ml
D-0712-2016papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0713-2016papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0714-2016papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0715-2016progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0716-2016testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots36 ml
D-0717-2016testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots10 ml
D-0718-2016papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705; All lots20 ml
Based on the official FDA remedy

What to do — step by step

  1. Stop using the medication

    Do not use any remaining doses of the recalled progesterone/testosterone oil due to sterility concerns.

  2. Contact your pharmacy or provider

    Reach out to Abbott's Compounding Pharmacy or your healthcare provider for instructions on disposal or replacement.

Where it went and when

Where it was distributed

Distributed in California.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Jan 15, 201612. FDA classified it Class II: Feb 17, 201623. Published in FDA’s Enforcement Report: Feb 24, 201634. FDA terminated the recall: Apr 6, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0715-2016 (January 15, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0715-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA