FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ U…
- Reason
- An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
- Published
- November 10, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
by MACLEODS PHARMA USA, INC
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
by Ultra Seal Corporation
- Reason
- Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Moisture Limits
- Published
- November 3, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
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
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Moisture Limits
- Published
- November 3, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Lupin Pharmaceuticals Inc.
- Reason
- Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- Published
- October 27, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
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
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
- Published
- October 27, 2021
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
by Teva Pharmaceuticals USA
- Reason
- Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
by Teva Pharmaceuticals USA
- Reason
- Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
by Teva Pharmaceuticals USA
- Reason
- Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
- Published
- October 27, 2021
- 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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