Teva Pharmaceuticals USA Inc recall records

29 reported ongoing

51 records in this archive. Latest source date Aug 24, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes...

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Class IIReported ongoing

Distribution: Product was distributed nationwide.

Official source for Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1...
FDA drug enforcement

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Ph...

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source for Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Cana...
FDA drug enforcement

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Class IIReported terminated

Distribution: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.

Official source for Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceutic...
FDA drug enforcement

Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Me...

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

Class IIReported terminated

Distribution: Nationwide in the U.S.A.

Official source for Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, U...

Reasons in these listed records

  • Presence of foreign tablets/capsules.
  • Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
  • Superpotent Drug
  • Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

These examples come from this result page and are not a ranking of every recall reason.

Checking Teva Pharmaceuticals USA Inc

Is there a recall on teva pharmaceuticals usa inc right now?

This archive contains 51 records, including 29 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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