the Compounder

the Compounder: 47 FDA recall reports

Every drug recall the FDA has published for the Compounder. The fault, and how the agency graded it.

47Reports
0Class I
0Ongoing
2015-11-18Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II47
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)

D-0204-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
12 (10mL) syringes

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)

D-0202-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
66 (10mL) syringes

BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PL

D-0212-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
10 (10mL) syringes

TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The

D-0227-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
120 capsules

ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testostero

D-0225-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
20 (10mL) syringes

BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML tran

D-0187-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
3 (10mL) syringes

BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/

D-0211-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
10 (3mL) syringes

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized):

D-0197-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized): DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
18 (10mL) syringes

BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transd

D-0193-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
30 (3mL) syringes, 9 (10mL) syringes

ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL an

D-0224-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
10 (3mL) syringes, 20 (1mL) syringes

ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosteron

D-0218-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
5 (10mL) syringes

E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) :

D-0213-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
120 capsules

TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal crea

D-0226-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 mL prefilled amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
24 (1mL) syringes

TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Co

D-0228-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
60 capsules

ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosteron

D-0217-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
6 (10mL) syringes

BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3

D-0182-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
3 (15mL) bottles

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)

D-0206-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
12 (10mL) syringes

BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone

D-0183-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
60 troches

BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micron

D-0184-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
90 capsules

BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Trans

D-0189-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
10 (3mL) syringes

ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0214-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
90 capsules

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transde

D-0194-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
6 (10mL) syringes

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Tra

D-0191-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
6 (10mL) syringes

ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefill

D-0216-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
40 (3mL) syringes

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)

D-0198-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
26 (10mL) syringes

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized)

D-0199-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
6 (10mL) syringes

ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL

D-0220-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
30 (3mL) syringes

ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0221-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
20 suppositories

BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polo

D-0210-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
20 (3mL) syringes

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weig

D-0207-2016  ·  Class II  ·  reported 2015-11-18  ·  Terminated

Why it was recalled
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Where it went
Nationwide
How much
5 (3mL) syringes

Showing the 30 most recent of 47. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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