FDA Recall
Terminated
Historical recordClass II
Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
by Herbal Doctor Remedies
- Reason
- CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
by Herbal Doctor Remedies
- Reason
- CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
by Herbal Doctor Remedies
- Reason
- CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
by Herbal Doctor Remedies
- Reason
- CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
by American Health Packaging
- Reason
- CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE SATSUMA AGE SK F; 20/ 150G; Net Wt. 5.2…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE AGE BALL SK F; 20/ 150G; Net Wt. 5.29 o…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE IKA MAKI SK F; 20/ 150G, Net Wt. 5.29 o…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE GOBO MAKI SK F: 20/ 150G, Net Wt. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE OHBAN AGE SK F; 20/ 150G; Net Wt. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakuku FISH CAKE MINCH BALL SK F; 20/ 150G; Net Wt. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE BOUTEN SK F 20/ 150G, Net Wt. 5.29 oz.…
- Reason
- Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wismettac Asian Foods, INC
- Product
- Shirakiku FISH CAKE IWASHI TEN SK F 20/150 g; Net WT. 5.29…
- Reason
- Fish Cake items contain possible contaminating undeclared milk and shellfish.
- Published
- August 14, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Mott's LLP
- Product
- Penafiel Mineral Spring Water 600mL (20.3 FL OZ) and Penafie…
- Reason
- Elevated levels of inorganic arsenic
- Published
- August 14, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01
by Piramal Critical Care, Inc.
- Reason
- Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
by LNK International, Inc.
- Reason
- Microbial contamination of non-sterile product
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
by MAJOR PHARMACEUTICALS
- Reason
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Published
- August 7, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
by ImprimisRx NJ
- Reason
- Subpotent Drug
- Published
- August 7, 2019
- 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.
Read the full medical disclaimer.