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 August 07, 2026 and include a total of 17860 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
D-0069-2022	10-12-2021	AllerClear 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 Limits	SUN PHARMACEUTICAL INDUSTRIES INC / 46,584 blister packs	Class III	Terminated
D-0155-2022	10-12-2021	TEST 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 50 vials	Class II	Terminated
D-0114-2022	10-12-2021	ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vials	Class II	Terminated
D-0174-2022	10-12-2021	TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vials	Class II	Terminated
D-0097-2022	10-12-2021	Estradiol 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 335 vials	Class II	Terminated
D-0112-2022	10-12-2021	ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 11 vials	Class II	Terminated
D-0124-2022	10-12-2021	MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 696 vials	Class II	Terminated
D-0186-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 24 vials	Class II	Terminated
D-0125-2022	10-12-2021	METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 324 vials	Class II	Terminated
D-0226-2022	10-12-2021	TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0144-2022	10-12-2021	SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 11 vials	Class II	Terminated
D-0117-2022	10-12-2021	HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vials	Class II	Terminated
D-0171-2022	10-12-2021	TESTOSTERONE 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 94 vials	Class II	Terminated
D-0210-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vials	Class II	Terminated
D-0153-2022	10-12-2021	TEST 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vials	Class II	Terminated
D-0201-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0211-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 22 vials	Class II	Terminated
D-0225-2022	10-12-2021	TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0120-2022	10-12-2021	IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 122 vials	Class II	Terminated
D-0145-2022	10-12-2021	SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vials	Class II	Terminated
D-0160-2022	10-12-2021	TEST 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0197-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0203-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vials	Class II	Terminated
D-0204-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vials	Class II	Terminated
D-0133-2022	10-12-2021	MIC 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0113-2022	10-12-2021	ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 15 vials	Class II	Terminated
D-0116-2022	10-12-2021	GOAL-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vials	Class II	Terminated
D-0217-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vials	Class II	Terminated
D-0127-2022	10-12-2021	MIC 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0122-2022	10-12-2021	L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vials	Class II	Terminated
D-0135-2022	10-12-2021	QUAD-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vials	Class II	Terminated
D-0115-2022	10-12-2021	ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 7 vials	Class II	Terminated
D-0213-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 8 vials	Class II	Terminated
D-0206-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 22 vials	Class II	Terminated
D-0166-2022	10-12-2021	TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vials	Class II	Terminated
D-0147-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 4 vials	Class II	Terminated
D-0159-2022	10-12-2021	TEST 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vials	Class II	Terminated
D-0100-2022	10-12-2021	ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0132-2022	10-12-2021	MIC 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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0200-2022	10-12-2021	TRI-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 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 5 vials	Class II	Terminated
D-0110-2022	10-12-2021	ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 2 vials	Class II	Terminated
D-0129-2022	10-12-2021	MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0102-2022	10-12-2021	ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 3 vials	Class II	Terminated
D-0103-2022	10-12-2021	ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 1 vial	Class II	Terminated
D-0143-2022	10-12-2021	SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 6 vials	Class II	Terminated
D-0220-2022	10-12-2021	TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 13 vials	Class II	Terminated
D-0161-2022	10-12-2021	TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247	Lack of assurance of sterility	Vita Pharmacy, LLC dba Talon Compounding Pharmacy / 19 vials	Class II	Terminated
D-0280-2022	10-12-2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50	Superpotent Drug	Teligent Pharma, Inc. / 52,104 glass bottles	Class I	Terminated
D-0092-2022	10-12-2021	Methocarbamol 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 91504	Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / a) 124, b) 29, c) 73	Class I	Completed
D-0281-2022	10-12-2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50	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. / 14,664 glass bottles	Class II	Terminated
D-0090-2022	10-12-2021	Irbesartan 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 only	CGMP Deviations: impurity N-nitrosoirbesartan detected in API	Lupin Pharmaceuticals Inc. / 98,052 bottles	Class II	Terminated
D-0068-2022	10-12-2021	Loratadine-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 Limits	SUN PHARMACEUTICAL INDUSTRIES INC / 22,752 blister packs	Class III	Terminated
D-0089-2022	10-12-2021	Irbesartan 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 only	CGMP Deviations: impurity N-nitrosoirbesartan detected in API	Lupin Pharmaceuticals Inc. / 63,408 bottles	Class II	Terminated
D-0279-2022	10-12-2021	Lidocaine 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 bottles	Class II	Terminated
D-0087-2022	10-12-2021	Irbesartan 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 API	Lupin Pharmaceuticals Inc. / 134,016 bottles	Class II	Terminated
D-0088-2022	10-12-2021	Irbesartan 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 API	Lupin Pharmaceuticals Inc. / 119,544 bottles	Class II	Terminated
D-0086-2022	10-12-2021	Irbesartan 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 API	Lupin Pharmaceuticals Inc. / 51,144 bottles	Class II	Terminated
D-0027-2022	10-08-2021	Imipramine 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 bottles	Class II	Terminated
D-0096-2022	10-05-2021	Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3 Package NDCs: 50090-5510-1; 50090-5510-3	Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.	A-S Medication Solutions LLC. / 72 bottles	Class III	Terminated
D-0082-2022	10-05-2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity	Dr. Reddy's Laboratories, Inc. / a) 30,839 bottles, b) 3,830 bottles	Class II	Terminated
D-0081-2022	10-05-2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles. Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity	Dr. Reddy's Laboratories, Inc. / a) 776 bottles, b) 84 bottles	Class II	Terminated
D-0085-2022	10-05-2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05 Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05	Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle	Dr. Reddy's Laboratories, Inc. / 696 bottles	Class II	Terminated
D-0084-2022	10-05-2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity	Dr. Reddy's Laboratories, Inc. / a) 11,590 bottles b) 3,585 bottles	Class II	Terminated
D-0083-2022	10-05-2021	Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Package NDCs: 43598-742-30; 43598-742-90; 43598-742-10; 43598-744-30; 43598-744-90; 43598-744-10; 43598-743-30; 43598-743-90; 43598-743-05; 43598-745-30; 43598-745-90; 43598-745-05	Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity	Dr. Reddy's Laboratories, Inc. / a) 3,444 bottles b) 469 bottles c) 142 bottles	Class II	Terminated
D-0026-2022	10-05-2021	Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1 Package NDCs: 70000-0232-1; 70000-0232-2; 70000-0232-3	CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.	Dr. Reddy's Laboratories, Inc. / 8,976 bottles	Class II	Terminated
D-0004-2022	10-04-2021	Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11	Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.	Akorn, Inc. / 10,210 bottles	Class II	Terminated
D-0253-2022	10-01-2021	Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 2,841,012 cans	Class I	Terminated
D-0238-2022	10-01-2021	LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 3,816,468 cans	Class II	Terminated
D-0245-2022	10-01-2021	Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 2,841,012 cans	Class II	Terminated
D-0247-2022	10-01-2021	LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 4,546,152 cans	Class I	Terminated
D-0237-2022	10-01-2021	LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 4,546,152 cans	Class II	Terminated
D-0241-2022	10-01-2021	Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 1,801,332 cans	Class II	Terminated
D-0250-2022	10-01-2021	Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105 Package NDCs: 11523-4162-1	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 738,432 cans	Class I	Terminated
D-0239-2022	10-01-2021	LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1. Package NDCs: 11523-0010-1; 11523-0010-2	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 77,076 cans	Class II	Terminated
D-0252-2022	10-01-2021	Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 592,416 cans	Class I	Terminated
D-0244-2022	10-01-2021	Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 592,416 cans	Class II	Terminated
D-0248-2022	10-01-2021	LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 3,816,468 cans	Class I	Terminated
D-0246-2022	10-01-2021	LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 2,817,468 cans	Class I	Terminated
D-0236-2022	10-01-2021	LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 2,817,468 cans	Class II	Terminated
D-0249-2022	10-01-2021	Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2. Package NDCs: 11523-0010-1; 11523-0010-2	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 579,456 cans	Class I	Terminated
D-0243-2022	10-01-2021	Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3. Package NDCs: 11523-0165-3	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 4,990,860 cans	Class II	Terminated
D-0240-2022	10-01-2021	LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Package NDCs: 11523-0010-1; 11523-0010-2	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 579,456 cans	Class II	Terminated
D-0251-2022	10-01-2021	Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3. Package NDCs: 11523-0165-3	Chemical Contamination: presence of benzene	Bayer Healthcare Pharmaceuticals Inc. / 4,990,860 cans	Class I	Terminated
D-0254-2022	10-01-2021	LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2 Package NDCs: 11523-0010-1; 11523-0010-2; 0004110059	cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 579,456 units	Class II	Terminated
D-0242-2022	10-01-2021	Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981 Package NDCs: 11523-4162-1; 11017-410-00	cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.	Bayer Healthcare Pharmaceuticals Inc. / 738,432 cans	Class II	Terminated
D-0017-2022	09-30-2021	Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7	cGMP Deviations	Beiersdorf Inc / 14,748 cans	Class II	Terminated
D-0016-2022	09-30-2021	Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4	cGMP Deviations	Beiersdorf Inc / 70,320 cans	Class II	Terminated
D-0011-2022	09-30-2021	Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4	Chemical contamination; presence of benzene	Beiersdorf Inc / 167,808 cans	Class I	Terminated
D-0014-2022	09-30-2021	Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9	Chemical contamination; presence of benzene	Beiersdorf Inc / 143,376 cans	Class I	Terminated
D-0015-2022	09-30-2021	Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0	cGMP Deviations	Beiersdorf Inc / 36,660 cans	Class II	Terminated
D-0013-2022	09-30-2021	Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1	Chemical contamination; presence of benzene	Beiersdorf Inc / 142,236 cans	Class I	Terminated
D-0012-2022	09-30-2021	Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7	Chemical contamination; presence of benzene	Beiersdorf Inc / 124,668 cans	Class I	Terminated
D-0010-2022	09-30-2021	Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0	Chemical contamination; presence of benzene	Beiersdorf Inc / 38,328 cans	Class I	Terminated
D-0364-2022	09-28-2021	The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4	Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8	Revive Personal Products Company / 258 bottles	Class II	Ongoing
D-0257-2022	09-28-2021	Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA	Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 574 Bottles	Class III	Ongoing
D-0256-2022	09-28-2021	Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.	Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals / 119 Bottles	Class III	Ongoing
D-0002-2022	09-27-2021	Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.	Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.	AMIVAS (US), LLC / 292 cartons	Class II	Terminated
D-0006-2022	09-27-2021	Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07. Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08	Failed Dissolution Specifications	Strides Pharma Inc. / 1813 bottles	Class II	Terminated
D-0009-2022	09-24-2021	Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01	SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.	Eli Lilly & Company / 19,174 syringes	Class I	Terminated
D-0855-2021	09-23-2021	Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01 Package NDCs: 69367-174-01	Finished product specification did not meet USP specifications.	Monarch PCM, LLC / 11,419 tubes	Class II	Terminated