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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

the Compounder: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Agency Publication Date: November 10, 2015
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Affected Products

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.

Lot # 12192014:35@1, Exp 6/17/2015; Lot # 02202015:68@46, Exp 8/19/15

Lot Numbers:
12192014
02202015
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.

Lot # 12312014:91@6, Exp 3/31/2015

Lot Numbers:
12312014
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.

Lot # 12312014:44@4, Exp 12/31/2015

Lot Numbers:
12312014
Product: BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 02182015:78@22, Exp 2/18/2016; Lot # 02182015:98@23, Exp 2/18/2016

Lot Numbers:
02182015
02182015
Product: BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01162015:59@13, Exp 1/16/2016

Lot Numbers:
01162015
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.

Lot # 01232015:03@14, Exp 4/23/2015

Lot Numbers:
01232015
Product: BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 12232014:11@21, Exp 6/21/2015

Lot Numbers:
12232014
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.

Lot # 03022015:71@18, Exp 8/29/2015

Lot Numbers:
03022015
Product: BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01232015:75@4, Exp 7/22/2015

Lot Numbers:
01232015
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.

Lot # 01262015:27@46, Exp 8/14/2015

Lot Numbers:
01262015
Product: BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01232015:17@35, Exp 8/11/2015

Lot Numbers:
01232015
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.

a) Lot # 12162014:22@32, Exp 6/14/2015; Lot # 01122015:42@45, Exp 7/11/2015; b) Lot # 01212015:65@5, Exp 7/20/2015

Lot Numbers:
12162014
01122015
01212015
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.

Lot # 02062015:50@2, Exp 8/25/2015

Lot Numbers:
02062015
Product: BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 12222014:95@21, Exp 6/20/2015

Lot Numbers:
12222014
Product: BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01132015:97@2, Exp 4/13/2015

Lot Numbers:
01132015
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.

Lot # 12112014:43@19, Exp 6/9/2015

Lot Numbers:
12112014
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.

Lot # 12172014:08@24, Exp 6/15/2015

Lot Numbers:
12172014
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.

Lot # 01132015:45@15, Exp 7/12/2015

Lot Numbers:
01132015
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 3: 25: 1.25: 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.

Lot # 01232015:29@51, Exp 7/22/2015

Lot Numbers:
01232015
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 6.5 : 30: 1.25: 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.

Lot # 01232015:52@49, Exp 7/22/2015

Lot Numbers:
01232015
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.

Lot # 02022015:66@40, Exp 8/1/2015; Lot # 03022015:62@26, Exp 8/29/2015; Lot # 03062015:66@10, Exp by 9/2/2015

Lot Numbers:
02022015
03022015
03062015
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) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 02252015:80@18, Exp 8/24/2015

Lot Numbers:
02252015
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.

Lot # 01152015:68@24, Exp 7/14/2015; and Lot # 02192015:15@12, Exp 8/18/2015

Lot Numbers:
01152015
02192015
Product: BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01122015:21@8, Exp 7/11/2015; Lot # 02092015:09@4, Exp 8/8/2015; Lot # 03092015:66@35, Exp 9/5/2015

Lot Numbers:
01122015
02092015
03092015
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.

Lot # 01122015:25@6, Exp 7/11/2015; Lot # 03042015:64@14, Exp 8/31/2015

Lot Numbers:
01122015
03042015
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.

Lot # 01052015:78@27, Exp 7/4/2015

Lot Numbers:
01052015
Product: BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

a) Lot # 12292014:90@21, Exp 6/27/2015; b) Lot # 02032015:55@13, Exp 8/2/2015

Lot Numbers:
12292014
02032015
Product: BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01052015:05@12, Exp 7/4/2015

Lot Numbers:
01052015
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.

Lot # 12102014:93@49, Exp 6/8/2015

Lot Numbers:
12102014
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.

Lot # 02182015:05@17, Exp 8/17/2015

Lot Numbers:
02182015
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.

Lot # 12242014:95@3, Exp 6/22/2015; Lot # 02042015:29@7; Exp 8/3/2015

Lot Numbers:
12242014
02042015
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.

Lot # 02172015:64@24, Exp 5/18/2015

Lot Numbers:
02172015
Product: ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01142015:26@28, Exp 1/14/2016

Lot Numbers:
01142015
Product: ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01282015:71@21, Exp 7/27/2015

Lot Numbers:
01282015
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.

Lot # 12172014:36@7, Exp 6/15/2015; Lot # 02202015:63@45, Exp 8/19/2015

Lot Numbers:
12172014
02202015
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.

Lot # 01132015:27@20, Exp 7/12/2015

Lot Numbers:
01132015
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.

Lot # 01162015:90@26, Exp 7/15/2015

Lot Numbers:
01162015
Product: ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 12102014:82@10, Exp 6/8/2015

Lot Numbers:
12102014
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.

Lot # 12292014:45@12, Exp 6/27/2015; Lot # 01282015:06@16, Exp 7/27/2015; Lot # 03022015:06@38, Exp 8/29/2015

Lot Numbers:
12292014
01282015
03022015
Product: ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01132015:97@2, Exp 4/13/2015

Lot Numbers:
01132015
Product: ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 12302014:27@3; use by 6/28/2015; and Lot # 02252015:26@3; use by 8/24/2015

Lot Numbers:
12302014
02252015
Product: ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Lot # 01232015:87@5, Exp 7/22/2015

Lot Numbers:
01232015
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.

a) Lot # 12292014:32@20, Exp 6/27/2015; b) Lot # 01082015:73@21, Exp 7/7/2015

Lot Numbers:
12292014
01082015
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.

Lot # 12182014:10@21, Exp 6/16/2015; Lot # 01292015:64@13, Exp 7/28/2015

Lot Numbers:
12182014
01292015
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.

Lot # 12222014:81@25, Exp 6/20/2015

Lot Numbers:
12222014
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.

Lot # 12302014:78@17, Exp 12/30/2015, Lot # 03032015:04@4, Exp 3/2/2016

Lot Numbers:
12302014
03032015
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.

Lot # 01222015:18@3, Exp 7/21/2015

Lot Numbers:
01222015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71535
Status: Resolved
Manufacturer: the Compounder
Manufactured In: United States
Units Affected: 47 products (3 (15mL) bottles; 60 troches; 90 capsules; 240 capsules; 180 capsules; 3 (10mL) syringes; 5 (3mL) syringes; 10 (3mL) syringes; 5 (3mL) syringes; 6 (10mL) syringes; 9 (1mL) syringes; 30 (3mL) syringes, 9 (10mL) syringes; 6 (10mL) syringes; 36 (1 mL) syringes; 15 (3 mL) syringes; 18 (10mL) syringes; 26 (10mL) syringes; 6 (10mL) syringes; 12 (10mL) syringes; 12 (10mL) syringes; 66 (10mL) syringes; 18 (10mL) syringes; 12 (10mL) syringes; 15 (5mL) syringes; 12 (10mL) syringes; 5 (3mL) syringes; 1(1mL) syringe, 56 (3mL) syringes; 6 (10mL) syringes; 20 (3mL) syringes; 10 (3mL) syringes; 10 (10mL) syringes; 120 capsules; 90 capsules; 3 (10mL) syringes; 40 (3mL) syringes; 6 (10mL) syringes; 5 (10mL) syringes; 9 (5mL) syringes; 30 (3mL) syringes; 20 suppositories; 10 (3mL) syringes; 6 (5mL) syringes; 10 (3mL) syringes, 20 (1mL) syringes; 20 (10mL) syringes; 24 (1mL) syringes; 120 capsules; 60 capsules)

Were You Affected by This Recall?

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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 · 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.