Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0150-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0196-202210-12-2021TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0222-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0218-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0149-202210-12-2021VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 23 vialsClass IITerminated
D-0109-202210-12-2021CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 15 vialsClass IITerminated
D-0130-202210-12-2021MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0178-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 334 vialsClass IITerminated
D-0224-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0158-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0187-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0101-202210-12-2021ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0198-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0104-202210-12-2021ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0179-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1229 vialsClass IITerminated
D-0170-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0162-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0156-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0146-202210-12-2021TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/25MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0215-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0169-202210-12-2021TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 168 vialsClass IITerminated
D-0157-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0131-202210-12-2021MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0193-202210-12-2021TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0281-202210-12-2021Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.Teligent Pharma, Inc. / 14,664 glass bottlesClass IITerminated
D-0125-202210-12-2021METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 324 vialsClass IITerminated
D-0112-202210-12-2021ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 11 vialsClass IITerminated
D-0069-202210-12-2021AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Package NDCs: 63981-724-15
Failed Moisture LimitsSUN PHARMACEUTICAL INDUSTRIES INC / 46,584 blister packsClass IIITerminated
D-0114-202210-12-2021ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialsClass IITerminated
D-0174-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0199-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0124-202210-12-2021MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 696 vialsClass IITerminated
D-0186-202210-12-2021TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 24 vialsClass IITerminated
D-0153-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0155-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 50 vialsClass IITerminated
D-0201-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0211-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 22 vialsClass IITerminated
D-0097-202210-12-2021Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 335 vialsClass IITerminated
D-0207-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0117-202210-12-2021HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0171-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 94 vialsClass IITerminated
D-0144-202210-12-2021SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 11 vialsClass IITerminated
D-0210-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0226-202210-12-2021TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0202-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0194-202210-12-2021TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0107-202210-12-2021BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0214-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 50 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0121-202210-12-2021IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 99 vialsClass IITerminated
D-0173-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0154-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0099-202210-12-2021ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0148-202210-12-2021ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 23 vialsClass IITerminated
D-0191-202210-12-2021TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 5.88/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0175-202210-12-2021TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0142-202210-12-2021QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0181-202210-12-2021TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 7 vialsClass IITerminated
D-0205-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 2.5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 30 vialsClass IITerminated
D-0208-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vialsClass IITerminated
D-0126-202210-12-2021METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0129-202210-12-2021MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0143-202210-12-2021SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0110-202210-12-2021ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vialsClass IITerminated
D-0220-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IITerminated
D-0161-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 19 vialsClass IITerminated
D-0102-202210-12-2021ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0103-202210-12-2021ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0147-202210-12-2021TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0159-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IITerminated
D-0132-202210-12-2021MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0100-202210-12-2021ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0200-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vialsClass IITerminated
D-0116-202210-12-2021GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vialsClass IITerminated
D-0127-202210-12-2021MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0166-202210-12-2021TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vialsClass IITerminated
D-0206-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 22 vialsClass IITerminated
D-0203-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1.5/PGE-1 50 INJ **ST 1** INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0213-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 8 vialsClass IITerminated
D-0217-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0122-202210-12-2021L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0115-202210-12-2021ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 7 vialsClass IITerminated
D-0160-202210-12-2021TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0135-202210-12-2021QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vialsClass IITerminated
D-0197-202210-12-2021TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0120-202210-12-2021IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 122 vialsClass IITerminated
D-0145-202210-12-2021SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vialsClass IITerminated
D-0225-202210-12-2021TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0204-202210-12-2021TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vialsClass IITerminated
D-0133-202210-12-2021MIC B12 25/50/50/1+B6 100 MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vialClass IITerminated
D-0113-202210-12-2021ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247Lack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy / 15 vialsClass IITerminated
D-0092-202210-12-2021Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg TabletsBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / a) 124, b) 29, c) 73Class ICompleted
D-0280-202210-12-2021Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50Superpotent DrugTeligent Pharma, Inc. / 52,104 glass bottlesClass ITerminated
D-0089-202210-12-2021Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 63,408 bottlesClass IITerminated
D-0090-202210-12-2021Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx onlyCGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 98,052 bottlesClass IITerminated
D-0068-202210-12-2021Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Package NDCs: 0904-5833-15; 0904-5833-48
Failed Moisture LimitsSUN PHARMACEUTICAL INDUSTRIES INC / 22,752 blister packsClass IIITerminated
D-0279-202210-12-2021Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Package NDCs: 63739-997-64
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.Teligent Pharma, Inc. / 7,008 glass bottlesClass IITerminated
D-0087-202210-12-2021Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 134,016 bottlesClass IITerminated
D-0088-202210-12-2021Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 119,544 bottlesClass IITerminated
D-0086-202210-12-2021Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Package NDCs: 68180-410-06; 68180-410-09; 68180-411-02; 68180-411-06; 68180-411-09; 68180-412-02; 68180-412-06; 68180-412-09
CGMP Deviations: impurity N-nitrosoirbesartan detected in APILupin Pharmaceuticals Inc. / 51,144 bottlesClass IITerminated
D-0027-202210-08-2021Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Package NDCs: 68180-314-06; 68180-314-01; 68180-315-06; 68180-315-01; 68180-316-06; 68180-316-01; 68180-317-06; 68180-317-01
Out of specification result observed in a dissolution test at the 9-month long term stability time point.Lupin Pharmaceuticals Inc. / 1,902 bottlesClass IITerminated