Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 23, 2015 (11 years ago)

Bi-Est (estriol,estradiol)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Cause type: Cross-contamination

Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.

What was recalled

Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA

Drug: Testosterone

Recalling firm
South Coast Specialty Compounding, Inc.
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1410-2015 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Testosterone recalls

See all
Class II · Moderate risk

Testosterone 200mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0329-2026
Class II · Moderate risk

Testosterone 100mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0328-2026
Class II · Moderate risk

Testosterone 75mg

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0327-2026

Other recalls by South Coast Specialty Compounding, Inc.

All 2015 recalls
Class II · Moderate risk

Bi-Est (estriol,estradiol)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1415-2015
Class II · Moderate risk

Bi-Est (estriol,estradiol)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1414-2015
Class II · Moderate risk

Estradiol cream

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1413-2015
Class II · Moderate risk

Bi-Est (estriol,estradiol)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Terminated Cross-contamination South Coast Specialty Compounding, Inc. D-1412-2015