Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

621 recalls · Class II, newest first

Class II · Moderate risk

Brevibloc Premixed Injection

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 10019-055-61 D-1413-2014
Class II · Moderate risk

Mesalamine

Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.

Terminated Particulate / foreign matter Cambrex Charles City Inc D-0447-2017
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-10 D-1429-2014
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-02 D-1428-2014
Class II · Moderate risk

Famotidine Injection 20 mg

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-5197-41 D-0293-2015
Class II · Moderate risk

Pristiq (desvenlafaxine)

Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.

Terminated Particulate / foreign matter Pfizer Us Pharmaceutical Group NDC 0008-1211-30 D-1409-2014
Class II · Moderate risk

Tikosyn¿ (dofetilide)

Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).

Terminated Particulate / foreign matter Pfizer Inc. NDC 00069-5820-60 D-1253-2014
Class II · Moderate risk

Ranitidine Tablets USP

Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.

Terminated Particulate / foreign matter Glenmark Generics Inc., USA NDC 68462-248-05 D-1229-2014
Class II · Moderate risk

Perrigo

Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.

Terminated Particulate / foreign matter Paddock Laboratories, LLC NDC 0574-0129-01 D-1168-2014
Class II · Moderate risk

etomidate injection

Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.

Terminated Particulate / foreign matter Agila Specialties Private Ltd. NDC 0069-0006-02 D-1225-2014
Class II · Moderate risk

BUPivacaine HCl 0.25% Preservative Free

Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.

Terminated Particulate / foreign matter Healix Infusion Therapy, Inc. NDC 75901-7210-53 D-1422-2014
Class II · Moderate risk

Atorvastatin Calcium Tablets

Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.

Terminated Particulate / foreign matter Ranbaxy Inc. NDC 63304-827-90 D-1086-2014
Class II · Moderate risk

Guaifenesin USP

Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.

Terminated Particulate / foreign matter Traxx International Corp D-1165-2014

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