FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 1, 2022Historical recordClass I
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
by Blaine Labs Inc
- Reason
- Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 2, 2022Historical recordClass I
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
by Walmart Stores
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 16, 2023Historical recordClass II
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
by B. Braun Medical, Inc.
- Reason
- Lack of sterility assurance: leaking bags
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2023Historical recordClass II
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
by The Harvard Drug Group
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 6, 2022Historical recordClass II
FDMR, INC DBA SUJI'S KOREAN CUISINE
- Product
- Taiyaki Variety Pack; 21.6 oz. (600g) 30 fish waffles in a…
- Reason
- Hazelnuts were declared in ingredient statement but not in Contains statement.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 9, 2022Historical recordClass II
Swanson Health Products, Inc
- Product
- Swanson Ultra: Vitamin B12 Methylcobalamin High Absorption…
- Reason
- Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 22, 2022Historical recordClass I
Gourmet Kitchen, Inc.
- Product
- 14" Raw Buttermilk Breakfast Tart with Fresh Blueberries &…
- Reason
- Undeclared almonds
- Published
- March 23, 2022
- Distribution
- Distributed to 4 distributors and 21 dir…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 22, 2022Historical recordClass I
Gourmet Kitchen, Inc.
- Product
- 14" Raw Buttermilk Breakfast Tart with Cranberries, Apples &…
- Reason
- Undeclared almonds
- Published
- March 23, 2022
- Distribution
- Distributed to 4 distributors and 21 dir…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 24, 2022Historical recordClass I
Mohammad Mayha
- Product
- Helmi Honey VIP packaged in a gold paper box with black writ…
- Reason
- Contains hidden drug ingredient
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 24, 2022Historical recordClass I
Mohammad Mayha
- Product
- Jaguar Power Honey packaged in a gold paper box with black w…
- Reason
- Contains hidden drug ingredient
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 15, 2022Historical recordClass II
Herbalife International of America
- Product
- Herbalife NutritionProtein Bar Deluxe - Chocolate Peanut fla…
- Reason
- Undeclared allergen - egg
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2023Historical recordClass II
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
by American Health Packaging
- Reason
- Impurity failure at 0-time of the repackaged lot.
- Published
- March 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 8, 2023Historical recordClass II
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications
- Published
- March 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Abbott Laboratories
- Product
- Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can…
- Reason
- Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced
- Published
- March 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Abbott Laboratories
- Product
- Abbott Infant Formula Powder 12.6oz. can. 6 cans per case.…
- Reason
- Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced
- Published
- March 16, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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