Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.
BayCare Central Pharmacy is recalling Succinylcholine Chloride 100 mg/5 mL syringes due to lack of sterility assurance. The affected lot was distributed in Florida.
Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.
Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.
Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.
Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with Moisturizer due to failure to meet the required denaturant specification. The product was distributed to affiliated facilities and third-party recipients in nine states.
Cascade Kelly Holdings LLC is recalling Global Hand Sanitizer with moisturizer because the product does not meet the required denaturant specifications for alcohol-based antiseptics.
API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer Aloe Watermelon Lemonade due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.
Scentsational Soaps & Candles Inc is recalling SS Tangerine & Guava Scented Sanitizer (3.38 FL. OZ.) due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.
Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.
Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.
Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.
Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.
Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.
Nuri Trading LLC is recalling 69MODE Blue 69 capsules nationwide because they contain undeclared tadalafil and sildenafil, two FDA-approved drugs, making the product an unapproved drug without established safety or efficacy.
Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.
Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules nationwide because they contain undeclared prescription drug ingredients (tadalafil, sildenafil, and vardenafil) and lack FDA approval.
Goose Creek Hand Sanitizer aloe Limoncello (100 mL) is being recalled because the product contains methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Tropical Daydream spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.
Ulta beauty Fresh Lemon Citron Frais Hand Sanitizer Spray is being recalled because the product contains methanol, benzene, and acetaldehyde. Affected lot numbers are 20357A, 20358B, and 20363C with expiration date 12/1/2022.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Optimistic Vibes spray due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.
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